Company: SeQual Technologies Inc.Date: 7/18/01 Product: Oxygen Failure to ensure that a process whose results cannot be fully verified by subsequent inspection and testing, has been validated and approved according to established procedures [21 CFR 820.75(a)]. Specifically, your firm has no documented evidence that provides a high degree of assurance that the manufacturing specifications and...Read More

Company: Toshiba America Medical Systems, Inc.Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000 REASON: Wrong image presents to radiologist upon database query. MANUFACTURER/RECALLING FIRM: Toshiba America Medical Systems, Inc., Tustin, CA RECALL BY:...Read More

Company:Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE Z-0691-1 through Z-0693-1 Software used on the Computerized Tomography Fluoroscopy CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners REASON: X-ray generation without operator command using unusual program sequence. MANUFACTURER/RECALLING FIRM:...Read More

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Company: Paul E. Garland M.D.Date: 7/11/01 Product: Excimer Laser Medical devices used by doctors in their course of their practice to treat patients are “marketed” and “held for sale” within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). An excimer laser is a class III device under section 513(f) of the...Read More

RECALL NUMBER, PRODUCT AND CODE:Company: Community Blood Center of Greater Kansas City Date of Enforcement Report: 7/11/01 Class: II B-1457-1, Red Blood Cells Units L04250, L02615, M84346, T52350, T033222,T031302, T028101, T025140, T012049, T007397 B-1458-1, Platelets, Pheresis, Units T038725, T035305, T034495 B-1459-1, Platelets Units T031302, T012049, T007397 B-1460-1, Fresh Frozen Plasma Units L04250 (divided into 4...Read More

Date of Enforcement Report: 7/11/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0629-1, Multi-Therapy Ambulatory Infusion Pumps sold under the following labels a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump) and 606000-40I (International) b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832 REASON: Potential overinfusion in the Auto-Ramp mode...Read More

Company: EP MedSystemsDate: 7/10/01 Product: Cardiac Catheters Your firm failed to validate several computer databases that are used for quality functions including your Access database, your _____ software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i). FDA District: New JerseyRead More

Company: Cardinal Health Inc.Date: 7/10/01 Product: Drug Products Failure to have an adequate validation procedure for computerized spreadsheets used for in-process and finished product analytical calculations. The current validation procedure uses only the values that result in within specification findings, aberrant high findings, and aberrant low findings [21 CFR 211.165(e)]. For example, SOP 644.00, QA/QC...Read More

Company: SciOptic InternationalDate: 7/9/01 SciOptic has contended that the _____ could be considered as a “custom device” within the meaning of 21 CFR 812.3(b). FDA has previously informed you that the _____ is not a custom device as it does not meet the necessary criteria found in section 520(b) of the Act, or in 21...Read More

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Company: Aventis Bio-ServicesDate: 6/29/01 Product: Blood Products There are no written procedures and controls in place to assure that the manual permanently deferred donor files are checked when determining the suitability of new donors. Not all permanently deferred donors are included in your _____ computer system. In order to verify that a new donor is...Read More

Company: Transplantation Research FoundationDate: 6/25/01 Product Name: Dura mater allografts Failure to establish and maintain procedures to control product that does not conform to specified requirements [21 CFR 820.90]. For example, the computer disposition records did not clearly document the destruction of unsuitable dura mater, and there are no disposition procedures addressing the segregation and...Read More

Company: Marshall Medical Center North Date: 6/20/01 Product name: Mammography facility Note: The wording of this noncompliance was changed in the software to incorporate several other similar noncompliance issues. The finding is specific to corrective action for a failing image score not being documented FDA District: New Orleans DistrictRead More

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483Company: Schering-Plough Prodcuts, LLC City and Sate: Manati, Puerto Rico 00674-0486 FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1/01-6/13/01 You failed to have adequate security controls for your HPLC system, once accessed by one employee is left opened and available for other personnel to gain access to the original employee’s analytical test reports....Read More

Company: Electronic Data Systems (EDS)Enforcement Report Date: 6/13/01 Class: II PRODUCT: Defense Blood Standard System, Blood Bank Computer Software, – In use at 79 military facilities. Recall # B-897-1. REASON: Due to a defect in computer software, expired blood products that were returned, and units that were received at out of spec temperatures, were not...Read More

Company: Analogic CorportationDate: 6/13/01 Class: II PRODUCT: a) Philips Tomoscan M. Recall # Z-550-1. b) Philips Tomoscan EG. Recall # Z-551-1. c) Philips Tomoscan EG. Recall # Z-552-1. REASON: The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose. CODE: a) Philips Tomoscan M; b) Philips Tomoscan...Read More

483Company: Schering-Plough Prodcuts, LLC City and State: Las Pierdas, PR FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1-6/5-2001 You have not developed validation/qualification master plans encompassing process, cleaning computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999. You failed to have...Read More

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Recall of Amicus Separator Operating with Version 2.50 Software REASON: Baxter Healthcare Corporation is recalling Amicus Separators operating with version 2.50 software after discovering that the device may return an inappropriate volume of plasma to a donor during an apheresis procedure. This occurrence has been observed during single needle procedures using Amicus Separators operating with...Read More

The Validation Times Vol III, No. 5 May 2001 reported that James McCormack of FDA : 1. Indicated that the first two FDA Part 11 Guidances may be issued as early as June 2001. These would be the Glossary and Validation guidances. Scope would not be addressed. Other guidances would follow over a period of...Read More

Company: Instrumentation Laboratory Co. Date of Enforcement Report: 5/30/01 Class: III PRODUCT: ACL Futura Coagulation Analyzers. Recall #Z-577-1. REASON: There is a software error that may cause index file and record information to be mismatched. CODES: All Serial Numbers with software version below V3.4. MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA. RECALLED BY: Manufacturer, by letters,...Read More

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Company: Cardiomedics, Inc. Date of Enforcement Report: 5/30/01 Class: II PRODUCT: CardiAssist External Counter Pulsation (ECP)System. Recall #Z-573-1. REASON: The screen on the unit containing software version 1.4.3 intermittently locks up. Unexpected shutdown; deletion of use for cardiogenic shock. CODES: n/a MANUFACTURER: Cardiomedics, Inc., Irvine, CA. RECALLED BY: Manufacturer, by facsimile, dated April 4, 2001,...Read More

Company: Mediware Information Systems, Inc.Date: 5/29/01 REASON: The expiration date of a manufactured product may be mistakenly extended, without displaying a warning to the user, when entered under certain specific conditions. DATE RECALL INITIATED: May 29, 2001 PRODUCT / VERSIONS Hemocare Blood Bank Data Management System Software Software versions 5.1, 5.2, 5.2a, 5.2b for use...Read More

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Date of Enforcement Reporl: May 9,2001Class: II PRODUCT: ISS 2001 X-Ray Imaging System. Recall # Z-246-1. REASON: The systems fail to conform to design specifications relating to the emission of electronic product radiation. MANUFACTURER: Fischer Imaging Corporation,Denver, Colorado. RECALLED BY: Manufacturer, to supply new version (1.4) of software by May 1, 2002. Firm- initiated recall...Read More

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Company: Philips Medical Systems Nederland B.V.Date of Enforcement Report: 4/25/01 Date of Recall: February, 2001 Class: II PRODUCT: EasyVision CT/MR Workstation with software release 1.x AND 2.x. Recall #Z-0495-1. REASON: If Ct scans made on different dates, the Image sets are merged into one exam. CODES: EasyVision CT/MR Workstation with release RI.X and release. MANUFACTURER:...Read More

Company: Philips Medical System Nederland B.VDate of Enforcement Report: 4/25/01 Date of Recall: 5/1/97 Class: II PRODUCT: Gyroscan T5 Magnetic Resonance Diagnostic Device NT. Recall #Z-0500-1. REASON: If computer shuts down the system patient nurse call alarm is not activated. CODES: All Gyroscans delivered from factory since October 1996LOT NUMBER (S)OR S/N(S) Serial Numbers 182,...Read More

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Company: Stough Enterprises Date: 4/18/01 Product: Blood & Plasma Product Category: Biologics/Blood Failure to appropriately determine the suitability of donors prior to the collection and distribution of the blood product because on January 30, 2001, a donor screener was observed reading the questions too quickly for the donor to respond prior to the screener entering...Read More

Company: AvidcareWL Date: 4/17/01 Product: In home Asthma Monitoring System …”Under a United States Federal law, the Federal Food, Drug and Cosmetic Act (the Act), these products are considered to be medical devices because they are used to diagnose or treat a medical condition or to affect the structure or function of the body. Home...Read More

Company: Cardiomedics Inc.Date: 4/13/01 Product: Counter pulsation devices No procedures for the development of software used to control devices. The software used for the operation of the CardiAssist CounterPulsation system was not properly validated. Problems with this software have been identified and corrective measures have been undertaken to replace this software version. Electro Static Discharge...Read More

Company: GE Medical Systems Inc. SADate: 4/10/01 Product: Full Field Digital Mammography Device Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing...Read More

Company: Neuro Control Corp. Date: 4/9/01 Product: NeuroControl Freehand System Also, at the time of the meeting your firm was using a procedure entitled, “Return Inspection Procedure for the Freehand Backup Implantable Components”. As we stated in our meeting with your firm, this procedure appears to involve electronic record. The recent FDA inspection revealed that...Read More

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Company: Zeus Scientific Inc.Date: 3/27/01 Product: IVD test kits In addition to the above,your firm failed to validate the electronic documentation system used to record corrective action requests (CARs) prior to implementation. The electronic record requires electronic signature,for which there is no timestamp on the record. Also, you failed to certify to the FDA that...Read More

Company: Ortho-Clinical Diagnostics, Inc.Date of Enforcement Report: 3/21/01 Date of recall letter: 6/26/00 Class: II PRODUCT: a) Vitros 250 and Vitros 250 AT Chemistry Systems Software version below 7.0.; Recall #Z-386-1. b) Vitros 950 and Vitros 950AT Chemistry Systems with software version below 3.07. Recall #Z-387-1. REASON: The Bilirubin (Unconjugated Bilirubin) results may be reported...Read More