Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA device recall Z-2405-2012 · posted 2012-09-19 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
- Action taken
- Elekta sent an Important Field Safety Notice dated August, 2012 to inform users that inspection and possibly bolt replacement needs to be carried out. Users should return the signed acknowledgement to Elketa, and an inspection should be carried out under FCO20002103053. For questions customers should call +44(0)1293 654200. For questions regarding this recall call 770-300-9725.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 110
- Distribution
- Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto
- Date initiated
- 2012-08-06
- Date posted
- 2012-09-19
- Date terminated
- 2014-10-08
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932) | Elekta, Inc. | 2005-08-12 |