Leica Surgical Microscope Recall Due to Axis Brake Failure
Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
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: The recall is classified as FDA Class II. The hazard involves a mechanical failure (brake failure) in a medical device used for human and veterinary treatment, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Leica Microsystems (Schweiz) Ag is recalling 28 units of surgical microscopes. The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
The recall was initiated because the brake in the Z axis and/or brakes in the AB and C axes failed during installation. The affected units were distributed worldwide, including in the United States (nationwide, specifically in AK, CA, CO, NY, and OR) and in Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Leica Microsystems for further instructions on how to proceed with the recall.
The recalled product
- Product
- Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
- Manufacturer
- Leica Microsystems (Schweiz) Ag
- Hazard
- Affected units
- 28
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: OH5-45912
- OH5-46012
- OH5-46112
- OH5-46212
- OH5-46312
- OH5-46412
- OH5-46512
- OH5-46612
- OH5-46712
- OH5-46912
- OH5-47012
- OH5-47112
- OH5-47212
- OH5-47312
- OH5-47412
- OH5-47512
- OH5-47612
- OH5-47812
- OH5-47912
- OH5-48012
Distribution
Part of a larger recall action
This product is one of 2 recalled by Leica Microsystems (Schweiz) Ag 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 2 products in this recall →Related recalls
Same manufacturer · Leica Microsystems (Schweiz) Ag
See all →- HighLeica Surgical Microscope Recall Due to Brake Failure During Installation
FDA (Devices) · 2013-09-18
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