Siemens MRI Class II

PRODUCT

Magnetom 42 SP Magnetic Resonance Imaging System with

Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body:

a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A);

b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall #Z-664/665-0.

REASON

Patients who are registered on the MRI systems with birth dates of January 1, 2000 or later will be misinterpreted by the software to have been born in 1900.

MANUFACTURER

Siemens AG, Erlangen, Germany.

RECALLED BY

Siemens Medical Systems, Inc., Iselin, New Jersey, by letter dated February 24, 2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

Approximately 387 units.

SoftwareCPR keyword: Y2K, Year 2000

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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