Recall Z-0895-05 ยท HAW Neurological Stereotaxic Instrument
FHC, Inc.
FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
| Date | Jun 16, 2005 (initiated Mar 14, 2005) |
| Status | Terminated |
| Reason | Potential for non-sterile pin to contaminate sterile field |
| Root cause | Other |
| Action | FHC notified customers by letter dated 3/14/05 and 3/25/05. The firm has issued a temporary set of instructions which include covering the non-sterile engagement pin with sterile tape and an amended Instruction For Use page to all customers. A redesigned pulley cover which will be sent to all customer when it becomes available in April 2005. |
| Quantity | 169 units |
| Distribution | Natiowide |
| FDA record | Open on fda.gov |