Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Summary
The FDA issued a Class II for Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 by Leica Microsystems, Inc.. Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result.
Details
Source
Device Recall
External ID
Z-1849-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product Description
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Lot/Code Info: Serial Numbers: 210721001, 180721001, 190721001, 121021001, 100821001, 60821001, 90821001, 120821001, 10821001, 80721001, 40821001, 130821001, 290821001, 240821001, 91021001, 180921001, 181121001, 151021001, 190821001, 160921001, 20721001, 50721001, 40921001, 150821001, 160821001
Quantity Affected: 25 devices
Reason for Recall
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-26
Company
deerfield, IL
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 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Leica Microsystems, Inc. has 9 FDA actions in our database, including 9 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 (Leica Microsystems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Leica Microsystems, Inc. have FDA actions?
Leica Microsystems, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1849-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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