Reported May 27, 2015 · Terminated
Philips Healthcare DuraDiagnost X- Ray
Philips Medical Systems, 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, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Healthcare DuraDiagnost X- Ray
- Lot codes and dates
- DuraDiagnost Stationary X-ray System.
- Amount recalled
- 3 DuraDiagnost
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
- Nationwide
Why it was recalled
The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
This product could cause temporary or reversible health problems — stop using it.
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