Reported Aug 29, 2012 · Terminated

The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal…

Philips Medical Systems (Cleveland) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Road · Cleveland, OH · 44143-2131

Is this the product you have?

  • The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
  • Product UsageThe Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
Lot codes and dates
  • 119 of 119 codes

    • System Code # 728243
    • Serial #s: 7392
    • 7394
    • 7399
    • 7405
    • 7406
    • 7429
    • 7433
    • 7440
    • 7457
    • 7465
    • 7469
    • 7479
    • 7481
    • 7487
    • 7488
    • 7491
    • 7502
    • 7506
    • 7507
    • 7517
    • 7518
    • 7520
    • 7521
    • 7532
    • 7539
    • 7545
    • 7547
    • and 7556. System Code # 728244
    • Serial #s: 7190
    • 7195
    • 7318
    • 7383
    • 7427
    • 7430
    • 7510
    • and 7533. System Code #728256
    • Serial #s: 3163
    • 3500
    • 3500
    • 5623
    • 5655
    • 5655
    • 5666
    • 5670
    • 5715
    • 5724
    • 5747
    • 5773
    • 5776
    • 5813
    • 5836
    • 5855
    • 5862
    • 5868
    • 5877
    • 5897
    • 5911
    • 5911
    • 5916
Amount recalled
126 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Philips Medical Systems (Cleveland) Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 23, 2015 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.