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NCAR Recall
| Reference Number: |
mdprc 038 03 12 000 |
| Date submitted: |
3/10/2012 |
| Manufacturer: | Leica Microsystems Inc. |
| Device Type: | Ophthalmic surgical microscope |
| Description: | Ophthalmic, microscope |
| Medical Device Identifier: | Leica M820 C19, Leica M844 C19, Serial Numbers:
160806002, 61006001, 61006002, 300307001, 270407006,
110507002, 180607001, 130707001, 130707003, 81007003,
31207001, 31207002, 140508002, 26110801, 261108001,
261108002, 91208002, 101208001, 230909001, 151209002,
50510002, 160910008, 11010001, 101210002, 170910004,
260811001, 20911002
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| Reason of Field Safety Corrective Action: | The screws, which lock the bottom plate to spindle, pulled through and allowed the carrier arm with control panel/unit to fall. The carrier arm fell but wiring stayed attached and continued to suspend weight of arm. The carrier arm struck the right hand of the patient without injury. |
| Remedy Action: | Upon examination of the spindle that locks the carrier arm to the microscope column, the two screws that lock the lower assembly to the upper were pulled out. One had threads still on the tip and both screws were bent significantly.
Upgrade / replacement of the flange and axis of the touch panel / control unit carrier of Leica M820 C19 and Leica M844 C19 surgical microscopes (Article No. 10448194MO). The upgrade will be implemented to reduce the risk that screws, which lock the bottom plate to spindle, pull through allowing the carrier arm with touch panel / control unit to disconnect which potentially could result in them falling.
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| Athorized Representative/Importer/Distributor: | Al-Faisaliah Medical System, Riyadh, (01) 2119948 |
| Report Source: | NCAR |
| Source Ref. Number: | CH-2012-03-06-013 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: | No Attachments |
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