Jun

2003

Inc Class III Philips Medical Systems (Cleveland)

Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 6/04/03
Class: III

PRODUCT
a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Recall # Z-0835-03;
b) Philips MX8000 Dual v, Exp CT Scanner, utilizing V2.0 software.
Recall # Z-0836-03;

REASON
Patient images may be incorrectly stored in the archive directory of a different patient.

CODE
a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 3008 through 3169.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Highlands Heights, OH, by a “Product Safety Notification”, dated April 2, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
187 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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Inc Class III Philips Medical Systems (Cleveland)

Amy Sellers

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