Leica M320 Microscope Systems Recalled for Gas Spring Bracket Failure
Leica Microsystems is recalling 8,564 M320 Microscope Systems because screws holding the gas spring bracket may fail, causing the optics carrier to drop.
What this means for you
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 involves a mechanical defect in a medical device that could cause the optics carrier to drop, posing a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
Leica Microsystems, Inc. is recalling 8,564 Leica M320 Microscope Systems. The affected units are identified by Article Numbers 10448419, 10448420, 10448485, and 10448486. These devices are optical instruments intended for magnifying and illuminating specimens for observation, documentation, and human or veterinary medical treatment. They are not intended for use in eye operations.
The recall is due to a possible failure of the screws that hold the gas spring fixation bracket in place. If these screws fail, the gas spring, which is fixed to the upper part of the parallelogram, may not be able to hold up the weight of the optics carrier. This could result in the optics carrier dropping.
The affected units were distributed worldwide, including in the United States and numerous international locations. No specific illnesses or injuries are reported in the source text. Consumers and institutions should stop using the affected devices and contact Leica Microsystems for instructions on repair or replacement.
The recalled product
- Product
- Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for
- Manufacturer
- Leica Microsystems, Inc.
- Category
- Medical Device — Microscopes
- Affected units
- 8,564
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)
- A. Article Number 10448419 (Serial Numbers 160714001
- 10814001
- 200814001
- 200814002
- 90914001
- 021014001
- 21214001
- 31214001
- 81214001
- 190115001
- 190115002)
- B Article Number 10448420 (Serial Numbers 180514001
- 180514002
- 190514001
- 190514002
- 190514003
- 190514004
- 200514001
- 200514002
- 200514003
Distribution
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