Recall Z-0981-03 ยท GEX Powered Laser Surgical Instrument
A.R.C. Laser Corp
A.R.C. Laser Photolysis Probe/Handpiece
| Date | Jul 3, 2003 (initiated Jun 6, 2003) |
| Status | Terminated |
| Reason | Product may not have been properly sterilized. |
| Root cause | Other |
| Action | The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003. |
| Quantity | 370 units |
| Distribution | IN, NY, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993154 | LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM A.R.C. Laser Corp., Jun 29, 2000 |