Reported Jan 10, 2018 · Terminated
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector…
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
- Lot codes and dates
- 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
- Amount recalled
- 412
Why it was recalled
If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.
This product could cause temporary or reversible health problems — stop using it.
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