Summary
The FDA issued a Class II for CombiDiagnost R90 R1.1 by Philips North America. Reason: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a cert.
Details
Source
Device Recall
External ID
Z-1589-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
CombiDiagnost R90 R1.1
Lot/Code Info: REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114
Quantity Affected: 25 systems in total
Reason for Recall
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Distribution
US Nationwide
Type: FDA Mandated
Recall Initiated: 2023-03-03
Company
Cambridge, 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 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 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 North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1589-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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