28
May
2003

Philips Medical Systems (Cleveland) Inc Class III

0

Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 5/28/03
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 stored in the archive directory of a different patient.

CODE
a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 8008 through 8069.

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

VOLUME OF PRODUCT IN COMMERCE
a) 137 units;
b) 50 units.
DISTRIBUTION

Nationwide and Internationally

About the author

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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