Recall Z-0166-2010 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
| Date | Nov 10, 2009 (initiated Jul 1, 2009) |
| Status | Terminated |
| Reason | The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall. |
| Root cause | Labeling False and Misleading |
| Action | The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300. |
| Quantity | 107 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884912 | ANGIOSTAR Siemens Medical Solutions USA, Inc., Feb 16, 1989 |