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
