Recall Z-2083-2013 ยท IYE Accelerator, Linear, Medical
Brainlab AG
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a line
| Date | Aug 26, 2013 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap. |
| Root cause | Device Design |
| Action | BrainLab sent an "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" dated July 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the SRS QA Target Pointer. Consignees can instead use the Phantom Pointer feature until Brainlab can provide replacement hardware. Brainlab anticipates being able to provide all impacted facilities with replacement hardware by the end of July 2013. We sincerely apologize for any inconvenience and thank you in advance for your co-operation |
| Quantity | 6 units |
| Distribution | Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073018 | STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT Brainlab AG, Jan 23, 2008 |