Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes...
Leica Microsystems, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1725-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Leica Microsystems, Inc.
- 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 magnification and illumination.
- Product code
- OUE Micro Total Analysis Instrument System
- Reason for recall
- The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- A Medical Device Correction letter, dated September 11, 2013, was sent to all direct accounts. The letters advised customers that a Leica Microsystems representative will contact them and make arrangements to conduct an inspection of the ceiling mount(s) and to provide additional preventative maintenance and inspection protocols for the devices. Customers are asked to complete and return the enclosed Acknowledgement Form and send it back to Leica Microsystems within 10 days of receiving the Medical Device Correction letter. Customers with questions should contact their Leica Microsystems representative.
- Quantity in commerce
- 103 total
- Distribution
- Worldwide Distribution -- USA, including the states of AZ, IL, MA, MO, NC, OR, TX, VA, and WI; and, the countries of Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
- Product codes and lots
- Leica Ceiling Mount MSF-1; Article Numbers: 10446781, 10446782
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1725-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1726-2014 | Class II | Terminated | Voluntary: Firm initiated |
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