Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1725-2014Class II

Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes...

Leica Microsystems, Inc. / initiated 2013-09-11 / Terminated / root cause: manufacturing process

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
FDA enforcement reports joined to recall event Z-1725-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1725-2014Class IITerminatedVoluntary: Firm initiated
Z-1726-2014Class IITerminatedVoluntary: Firm initiated