Z-0311-2018Class II

Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable...

Name: Z-0311-2018 Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable...
Creator: Philips Electronics North America Corporation
Published: 2017-07-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-07-14 / Terminated

FDA source

Philips Electronics North America Corporation began a recall of 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... on 2017-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0311-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2018-01-03
Terminated: 2020-06-05
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 412
Distribution: 412 units affected.
Product codes and lots: 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0311-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0311-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-03

Product code KPR

K031535Class IIPhilips Easydiagnost ElevaPhilips Medical Systems North America Co. / cleared 2003-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)