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Terminated

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 Recall Z-0311-2018 · Posted None

Recall StatusTerminated
Product CodeKPR
Date Initiated2017-07-14
Date Terminated2020-06-05
Product Quantity412

Reason for Recall

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

412 units affected.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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