Leica Ceiling Mount MSF-1 Recalled Due to Broken Drive Screw
Leica Microsystems is recalling 103 MSF-1 ceiling mounts because a broken drive screw caused the lift arm to fall approximately 60 cm.
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 involves a mechanical failure in a medical device that resulted in a significant drop (60 cm) of a component, posing a risk of harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
Leica Microsystems, Inc. is recalling 103 units of the Leica Ceiling Mount MSF-1, intended for use with M841 and M501 operating microscopes. The recall involves Article Numbers 10446781 (230 V) and 10446782 (110 V). The product is intended to improve the visibility of objects through magnification and illumination.
The recall was initiated after a drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result of this failure, the lift arm fell down approximately 60 cm (23.6 inches). The affected units were distributed worldwide, including in the United States (AZ, IL, MA, MO, NC, OR, TX, VA, and WI) and in 21 other countries.
Users of these devices should contact Leica Microsystems, Inc. for further instructions on how to address the defect.
The recalled product
- Product
- Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through…
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 103
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 (3)
- Leica Ceiling Mount MSF-1
- Article Numbers: 10446781
- 10446782
Distribution
Part of a larger recall action
This product is one of 2 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.
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