Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves potential device malfunction during use. No injuries or deaths have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High severity.
Plain-English summary
Leica Microsystems, Inc. is recalling the Leica MICROSYSTEMS M530 OHX surgical microscope system (Part Number 10448737) due to a power supply overheating issue.
The power supply may become overheated due to internal components overstressing. When this occurs, a specific internal component can fail, causing the device to unexpectedly shutdown during use.
The recall affects 148 units distributed nationwide in the United States. Specific serial numbers are identified in the FDA recall documentation, with additional serial numbers added in an expansion issued on September 8, 2023.
The recalled product
- Product
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 148
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 10622001
- 10622002
- 10822001
- 20322002
- 20522001
- 20622001
- 30122001
- 30322001
- 30522001
- 30622002
- 30722001
- 31221001
- 40422001
- 41221001
- 50122001
- 60122001
- 60522001
- 60622001
- 70122001
- 70322001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Leica Microsystems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Leica Microsystems, Inc.
See all →- HighLeica Provido surgical microscope models at risk of unexpected power shutdown
FDA (Devices) · 2022-12-21
- HighSurgical microscope power supply may overheat and cause unexpected shutdown
FDA (Devices) · 2022-12-21
- ModerateLeica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination
FDA (Devices) · 2022-10-05
- HighLeica M530 Surgical Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
- HighLeica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
FDA (Devices) · 2022-10-05
Similar recalls
- HighLeica M530 OHX Microscope System Recalled for Power Module Design Weakness
FDA (Devices) · 2018-08-15
- HighLeica Surgical Microscopes Recalled for Potential Overheating and Smoke
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- HighLeica ARveo and M530 OH6 Microscope Systems Recalled for Voltage Issues
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- HighLeica M530 Surgical Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
- ModerateLeica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination
FDA (Devices) · 2022-10-05
- HighLeica Surgical Operating Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05