26
Jun
2002

Inc Class II Toshiba America Medical Systems

0

Company: Toshiba America Medical Systems, Inc
Date of Enforcement Report: 6/26/02
Class: II

PRODUCT
NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2.

REASON
Software anomally caused error in calculating VM_P.

CODE
Serial Numbers:
B1552349
C1572413
C1572414
C1572415
C1572417
C1572418
C1572420
C1572423
C1572428
C1572429
C1572430
C1572431
C1572432
C1572433
C1572421.

RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, CA, by letters dated February 22, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
15.

DISTRIBUTION
CA, ID, LA, MA, MD, MS, MT, OR and TX.

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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