Reported Aug 28, 2013 · Terminated
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR…
Philips Healthcare 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 Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810
Is this the product you have?
- Philips Healthcare MobileDiagnostwDR system. Mobile Digital
- radiography X-Ray System Product UsageMobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography
- Lot codes and dates
- System Code - 712001
- Amount recalled
- 240 systems US -- 1 system within Puerto Rico
Where it was sold
- Nationwide
- PR
Why it was recalled
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
This product could cause temporary or reversible health problems — stop using it.
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