Recall Z-3175-2018
Leica Microsystems, Inc. · initiated September 4, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Leica M525 F20 Surgical Microscope System
Codes / lots: Serial Numbers: 10714001 10813001 11010001 11010002 20312001 20316001 20513001 20518001 20813001 20911002 20916001 30112001 30412001 30616001 30813001 30813002 40112001 40310001 40510001 40610001 40916001 41215001 50218001 50813001 51011001 51015001 51116001 60218001 60317001 60415001 60813001 70116002 70414001 70714001 71010001 71011001 80114001 80212002 80316001 80513001 80611001 80817001 81014001 90317001 90610001 91117001 91215001 100310001 100317001 100616001 101211001 101216001 110110001 110112001 110116001 110310001 110517001 110809001 110816001 120116001 121216001 130313001 130813001 131010002 131011001 131115001 131211001 131212001 131216001 131216002 140214001 140413001 140612001 140813001 141209001 150415001 150612001 150813001 151013001 151116002 151210001 151211001 151211002 151215001 160216001 160313001 160418001 160810001 160911001 161210002 170310001 170809001 170811001 170916001 170917001 180116001 180117001 180213001 180216001 180511001 180610001 180612001 181111001 190214002 190309001 190316001 190813001 200418001 200910001 210115001 210214001 210316001 211010001 220715001 220909001 220916001 221010002 230909001 230910001 230916001 231109001 231116001 231213001…
Reason for recall
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
FDA-determined cause: Device Design
Action taken
The firm disseminated their Field Corrective Action Notices by mail beginning on 09/04/2018 to the US and Canadian consignees. The letter explained the problem and informed the consignee that an update package with enhanced instructions for use and additional marking will be provided within the next 3 months. Additional consignees found were notified by email on 10/01/2018.
Details
- Recall number
- Z-3175-2018
- Initiated
- September 4, 2018
- Posted by FDA
- September 14, 2018
- Terminated
- August 17, 2021
- Product code
- EPT – Microscope, Surgical
- Quantity
- 160 units
- Distribution
- US and Canada
- Recalling firm
- Leica Microsystems, Inc., Buffalo Grove, IL