Reported May 20, 2015 · Terminated

Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems,…

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?

  • Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
Lot codes and dates
  • 123 of 123 codes

    • Vertex Classic
    • Model #: 890122
    • Serial #s: 9404100
    • 9601238
    • 9609084
    • 0407V
    • 0682V
    • 0795V
    • 0822VP2
    • 103
    • 20
    • 500
    • 5405V
    • 64
    • 9308007
    • 9309020
    • 9310032
    • 93-10660-1292
    • 9401059
    • 9401061
    • 9403076
    • 9403083
    • 9404106
    • 9407122
    • 9409148
    • 9410002
    • 9411006
    • 9411007
    • 9411016
    • 9501049
    • 9501210
    • 9502067
    • 9502086
    • 9503003
    • 9503079
    • 9503109
    • 9504019
    • 9505021
    • 9505124
    • 9506140
    • 9508169
    • 9508171
    • 9508184
    • 9508193
    • 9509198
    • 9509206
    • 9510222
    • 9510226
    • 9601146
    • 9602249
    • 9608042
    • 9901004
    • B0106154
    • B02120033
    • M@10229AMT
    • M@207JD
    • M@4404V
    • M@4431V
    • M@4432V
    • M@4480V
  • VERTEX PLUS/SOLUS/CARDIO

    726 of 726 codes

    • Model #: 88297
    • Serial #s: 9603015
    • 9605036
    • 9610076
    • 9610077
    • 9703171
    • 9706192
    • 9710103
    • 9711277
    • 9802304
    • 9803109
    • 9807121
    • 9808122
    • 9809056
    • 9809124
    • 9809415
    • 9809424
    • 9912461
    • _0002032
    • ~9608052
    • 0007001M
    • 0008009B
    • 0011002B
    • 0102019V
    • 0103020V
    • 01069VM
    • 01070VM
    • 0111001V
    • 01295VM
    • 01296K
    • 01864VM
    • 03026VM
    • 0939VM
    • 100098-01N
    • 1006
    • 1008
    • 10252
    • 1027
    • 1037
    • 10630
    • 1092
    • 1097
    • 11
    • 130234-01NVERTEX
    • 2035
    • 2038
    • 2047
    • 3059
    • 3060
    • 3064
    • 4007
    • 4078
    • 5934V
    • 6052
    • 6261
    • 7373VM
    • 7376VM
    • 7386VM
    • 7560VM
    • 7561VM
Amount recalled
918 units

This recall covers 2 products

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

Where it was sold

Why it was recalled

During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.

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 Jun 26, 2018 · Data as of Sep 19, 5:28 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.