Reported Jul 29, 2015 · Terminated
Head Holder shipped with Ingenuity CT Computed Tomography X-ray 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?
- Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
- Lot codes and dates
- Head Holder M/N 4535 671 11331. Ingenuity CT M/N 728326, Serial #s: 6617, 10607, 10689, 32000, 300043, 300064, 300068, 300071, 300072, 300073, 300074, 300075, 300076, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 300086, 300087, 300088, 300089, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131 & 300132.
- Amount recalled
- 66 units
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
Why it was recalled
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
This product could cause temporary or reversible health problems — stop using it.
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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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