Recall Z-2630-2016 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Stryker Instruments Div. of Stryker Corporation
120 V Neptune 3 Rover, Model Number: 0703-001-000
| Date | Aug 23, 2016 (initiated Jul 1, 2016) |
| Status | Terminated |
| Reason | Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room. |
| Root cause | Under Investigation by firm |
| Action | Stryker Instruments initiated a voluntary recall of the Stryker Neptune 3 Rover via certified mail on 07/01/2016, due to the potential for the Neptune 3 Rover to experience system errors if there are high levels of electromagnetic interference in the operating room. 1. Immediately review the Recall Notification. 2. Confirm that the Rover serial numbers identified on the Business Reply Form (BRF) are at your facility. 3. A Stryker representative will facilitate the repair of your affected Neptune 3 Rover(s). Please coordinate the availability of the product to assure the repair can be im |
| Quantity | 78 |
| Distribution | Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153407 | Stryker Neptune 3 Waste Management System Stryker Corporation, Apr 25, 2016 |