Apr

2001

Phillips Gyroscan T5 Magnetic Resonance Class II

Company: Philips Medical System Nederland B.V
Date of Enforcement Report: 4/25/01
Date of Recall: 5/1/97
Class: II
PRODUCT:

Gyroscan T5 Magnetic Resonance Diagnostic Device NT.
Recall #Z-0500-1.

REASON:
If computer shuts down the system patient nurse call alarm is not
activated.

CODES:
All Gyroscans delivered from factory since October 1996LOT NUMBER (S)OR
S/N(S) Serial Numbers 182, 282, 364, 365, 372, 510, 543, 556, 628, 637,
640, 656, 680, 700, 701, 721, 795, 803, 824, 828, 865, 882, 897, 900,
904, 914, 1001-1003, 1005-1136, 1138-1149, 1151-1169, 4001-4135, 5002-
5005, 5007-5043, 5045-5050, 5052-5158, 5160-5170.

MANUFACTURER:

Philips Medical System Nederland B.V., Best, Netherlands.

RECALLED BY:
Philips Medical Systems North America, Inc., Shelton, CT., by field
service order on June 1, 1997. Firm-initiated recall ongoing.

DISTRIBUTION:Nationwide.

QUANTITY:81

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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Phillips Gyroscan T5 Magnetic Resonance Class II

Amy Sellers

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