Leica Ceiling Mounts Recalled Due to Broken Drive Screw
Leica Microsystems is recalling 103 ceiling mounts for M500 N microscopes 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 of a medical device that resulted in a significant drop of the lift arm. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it does not meet the criteria for Severe (4) which requires hospitalization reports or structural vehicle defects.
Plain-English summary
Leica Microsystems, Inc. is recalling 103 units of the Leica Ceiling Mount MS-1F and MC-1F, intended for use with the M500 N operating microscope. The affected units include Article Number 10446657 (110 V) and Article Number 10446658 (220 V). These devices are designed to improve the visibility of objects through magnification and illumination.
The recall was initiated after the supplier encountered an event where the 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 FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including in the United States (AZ, IL, MA, MO, NC, OR, TX, VA, and WI) and in Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. Users should contact Leica Microsystems for further instructions on how to address this defect.
The recalled product
- Product
- Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 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 (4)
- Leica Ceiling Mounts MS-1F
- MC-1F
- Article Numbers: 10446657
- 10446658
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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