Recall Z-1696-2016— Philips Healthcare
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare, initiated 2015-11-10, terminated 2017-05-03. It names one FDA 510(k) clearance: K141381. Product: Philips Healthcare DuraDiagnost stationary X-ray system. Reason: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image..
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-10
- Terminated
- 2017-05-03
- 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 Healthcare DuraDiagnost stationary X-ray system
Reason for recall
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
Data sourced from openFDA. This site is unofficial and independent of the FDA.