CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Leica Surgical Operating Microscopes, ARveo recalled
Leica Microsystems is recalling Leica Surgical Operating Microscopes, ARveo 8, distributed nationwide in the US. The recall was initiated on 26 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1848-2022
- FDA event ID
- 90818
- Recalling firm
- Leica Microsystems, deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2022
- FDA classified
- 29 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 26 Aug 2022 | Recall initiated by company | |
| 29 Sep 2022 | Classified by FDA | +34 days |
| 5 Oct 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001, 61221001, 81221001, 281121001, 291121001, 181121001, 300522001, 71221001, 20322001, 30322001, 60322001, 61221002, 21221001, 241121001, 101221001, 251121001, 31221001, 261121001, 91221002, 101221002, 51221001,
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90818This product is part of a recall event; the main page for the event is Leica Surgical Operating Microscopes, M530 OHX recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Leica Surgical Operating Microscopes, M530 OHX recalled | Leica Microsystems | Labeling Errors | Nationwide | |
| CLASS II | Leica Surgical Operating Microscopes, Arveo recalled | Leica Microsystems | Labeling Errors | Nationwide | |
| CLASS II | Leica Surgical Operating Microscopes, PROvido Part Numbers recalled | Leica Microsystems | Labeling Errors | Nationwide |
More recalls from Leica Microsystems
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Leica Microsystems Proveo 8, Part Number 10449058, surgical recalled | Leica Microsystems | Other | Nationwide |
| Device | CLASS II | Provido, Part Numbers 10448950 (Premium), 10448976 (Standard) recalled | Leica Microsystems | Other | Nationwide |
| Device | CLASS II | M530 OHX recalled by Leica Microsystems | Leica Microsystems | Other | Nationwide |
| Device | CLASS II | Leica Surgical Operating Microscopes, PROvido Part Numbers recalled | Leica Microsystems | Labeling Errors | Nationwide |
| Device | CLASS II | Leica Surgical Operating Microscopes, Arveo recalled | Leica Microsystems | Labeling Errors | Nationwide |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |