Summary
The FDA issued a Class II for Chromophare Surgical Light System , REF CH00000001 by Stryker Communications. Reason: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed..
Details
Source
Device Recall
External ID
Z-1506-2024
Action Date
2024-04-17
Status
Ongoing
Category
device
Product Description
Chromophare Surgical Light System , REF CH00000001
Lot/Code Info: S/N:03857056/ UDI: 07613327296167
Quantity Affected: 1 unit
Reason for Recall
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Distribution
US: None OUS: Chili
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-08
Company
Flower Mound, TX
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 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Communications has 3 FDA actions in our database, including 3 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 (Stryker Communications) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Communications have FDA actions?
Stryker Communications has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1506-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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