Recall Z-2555-2018 ยท EPT Microscope, Surgical
Leica Microsystems, Inc.
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 observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.
| Date | Jun 4, 2018 |
| Status | Terminated |
| Reason | Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. |
| Root cause | Nonconforming Material/Component |
| Action | Leica Microsystems notified customers on about 06/04/2018 via URGENT FIELD SAFETY NOTICE letter. The letter informed customers that they would be contacted by a Leica Microsystems representative to arrange for the field update in the next 12 months. Customers were instructed that they could continue to use the system pending the update if they ensure a functional check is performed prior to surgery and follow user manual directions. If any anomalies are noticed prior to the correction, customers should contact their Leica representative. Customers were also instructed to provide the notifi |
| Quantity | 8,564 Total Units |
| Distribution | Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.