Reported Dec 12, 2012 · Terminated
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for…
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 Digital Diagnost Software Version R2.0.2
- Product UsageThis system is used for making X-ray exposures for diagnostics
- Lot codes and dates
- All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
- Amount recalled
- 623 units
Where it was sold
- Nationwide
Why it was recalled
With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
This product could cause temporary or reversible health problems — stop using it.
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