Recall Z-2682-2016— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-09-17, terminated 2017-08-31. It names one FDA 510(k) clearance: K141381. Product: Philips DuraDiagnost stationary X-ray system. Reason: Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)]..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-17
- Terminated
- 2017-08-31
- 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 DuraDiagnost stationary X-ray system
Reason for recall
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Data sourced from openFDA. This site is unofficial and independent of the FDA.