Recall Z-0239-2022— Philips Healthcare
Class II · Ongoing
Class II FDA medical device recall by Philips Healthcare, initiated 2021-09-22. It names one FDA 510(k) clearance: K202564. Product: DigitalDiagnost C90. Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied..
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-22
- 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
DigitalDiagnost C90
Reason for recall
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Data sourced from openFDA. This site is unofficial and independent of the FDA.