Summary
The FDA issued a Class II for CombiDiagnost R90 is multi-functional general R/F systems. by Philips Healthcare. Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards..
Details
Source
Device Recall
External ID
Z-0241-2022
Action Date
2021-12-01
Status
Ongoing
Category
device
Product Description
CombiDiagnost R90 is multi-functional general R/F systems.
Lot/Code Info: CombiDiagnost R90
Quantity Affected: 281 in total
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.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2021-09-22
Company
Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Healthcare has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Healthcare have FDA actions?
Philips Healthcare has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0241-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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