21

Jan

2010

Cl Il GE ApexPro Oximeter systems

0

Company:General Electric Medical Systems Information Technology
Date of Enforcement Report 1/20/2010
Class:ll

PRODUCT
GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software). Recall # Z-0631-2010

REASON
Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator’s Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not documented in product labeling. 2. When ApexPro CH Xpod, ApexPro FH Xpod, or Apex Oximeter is connected to the ApexPro telemetry transmitter/transceiver, the SpO2 “No Data” Alarm does not function as specified in the ApexPro Operators Manual.

RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated September 25, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8305 units

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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