Recall Z-2465-2012— Philips Healthcare Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-09-06, terminated 2017-01-17. It names one FDA 510(k) clearance: K982795. Product: 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.. Reason: The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down.
- Recalling firm
- Philips Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-06
- Terminated
- 2017-01-17
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
Data sourced from openFDA. This site is unofficial and independent of the FDA.