Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
FDA Recall Z-2465-2012 · Posted 2012-09-27
Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-09-06
Date Terminated2017-01-17
Product Quantity93 Units
Reason for Recall
The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall
down
Firm Action
Philips Healthcare sent a Urgent Field Safety Notice dated August 13, 2012, to all affected customers. Notifications began the week of September 6, 2012, for US and Worldwide Customers. The letter identified the product the problem and the action needed to be taken by the customer.
Philips field service engineer will Secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (loctite).
Further information or support concerning this issue, contact your local Philips representative. 1-800-722-9377.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.
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.