03

Jul

2002

Philips Medical Systems Class II

0

Company: Philips Medical Systems
Date of Enforcement Report: 7/3/2002
Class: II

PRODUCT
Information Center System and Upgrades as follows:
a) M3150A Agilent or Virida Information center.
Recall # Z-1119-2;
b) M3151A Agilent or Virida Information Center Client.
Recall # Z-1120-2;
c) M3153A Agilent or Virida Surveillance Center.
Recall # Z-1121-2;
d) M3150AU#A01 Agilent or Virida Information Center Upgrade.

Recall # Z-1122-2.

REASON
Central Station Monitor may have a premature hard drive failure causing
the unit to shut down.

CODE
Systems distributed with a Hewlett Packard Vectra VL400 Personal Computer(PC),HP Part# P3715W with the following serial numbers:
US10204040 through US10710329
US10811665 through US10811789
US10902444
US10902817 through US10902887
US11304210
US11304576 through US11304670
US11307358
US11307974 through US11500994
US11608246
US11608393 through US11703817
US11704443
US11709038 through US11709052
US11800005
US11800291 through US11904733
US12104028
US12104584 through US12104621
US12106958
US12107167 through US12107365
US12203988
US12203996 through US12204354
US12210341
US12210494 through US12210535
US12210537
US12210539 through US12210575
US12210579
US12210581
US12210583 through US12210622
US12403504
US12403528 through US12408065
US12408067
US12408070 through US12408085
US12608928
US12609515 through US12609752
US12609757 through US12609883
US12618799
US12618806 through US12618807

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, formerly Agilent Technologies, Andover, MA, by letter on April 2, 2002.
Manufacturer: Philips Medical Systems, Andover, MA.Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,296.

DISTRIBUTION
Nationwide.

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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