Reported Feb 14, 2018 · Terminated

BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual…

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 Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • BrightView X, Model #882478
  • Product UsageBrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only)
Lot codes and dates
  • BrightView X, Model # 882478
  • Serial Numbers

    118 of 118 codes

    • 11000044
    • 11000006
    • 11000033
    • 11000025
    • 11000105
    • 11000016
    • 11000072
    • 11000116
    • 11000003
    • 11000018
    • 11000066
    • 11000047
    • 11000101
    • 11000065
    • 11000114
    • 11000078
    • 11000051
    • 11000046
    • 11000026
    • 11000007
    • 11000010
    • 11000027
    • 11000032
    • 11340001
    • 11000055
    • 11000070
    • 11000084
    • 11000088
    • 11000068
    • 11000052
    • 11000057
    • 11000050
    • 11000067
    • 11000102
    • 11000061
    • 11000095
    • 11000023
    • 11000094
    • 11000060
    • 11000054
    • 11340004
    • 11000083
    • 11000091
    • 11000098
    • 4000570
    • 11000063
    • 11000062
    • 11000013
    • 11000015
    • 11000035
    • 11000081
    • 11000009
    • 11000017
    • 11000110
    • 11000090
    • 11000107
    • 11340003
    • 11000056
    • 11000029
    • 11000100
Amount recalled
1387 in total

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Where it was sold

  • Nationwide

Why it was recalled

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 10, 2020 · Data as of Sep 19, 6:07 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.