Recalls / —
—#160639
Product
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.
- FDA product code
- KPR — System, X-Ray, Stationary
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K031535
- Affected lot / code info
- 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
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.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
If the lock mechanism of the movable clamp 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. The Wireless Portable Detector (WPD) is fixed in the Mobile Detector Holder via a lock mechanisrn. The 4 countersunk screws, that are used to attach the lock mechanism, can become loose. If this happens and the mechanism fails, the detector may fall down when the holder is rotated 90 clockwise from Iandscape.
Recalling firm
- Firm
- Philips Electronics North America Corporation
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- 412 units affected.
Timeline
- Recall initiated
- 2017-07-14
- Terminated
- 2020-06-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160639. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.