Recall Z-2058-2018 ยท REM Spectroscopy Instrument
Zeiss, Carl Inc
Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.
| Date | Jun 9, 2018 (initiated May 8, 2018) |
| Status | Terminated |
| Reason | In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 1.Your firm will send an initial email to all known users advising them of the issue, the risk involved and associated mitigations until the units can be evaluated by Carl Zeiss service representatives, 2.Your firm will send a second written communication to each first line purchaser and to each known user site with the notice of action and warning to discontinue use of the component until it has been verified as defective or properly functioning, and 3.Your firm will dispatch factory trained service representatives to perform verification tests and to replace defective units as necessary, f |
| Quantity | 1070 units to US |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.