Recall Z-1187-2012 ยท IYE Accelerator, Linear, Medical
Integra LifeSciences Corp
Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the TomoTherapy HiArt (Torno) System The Integra InterFix CT Adapter (CTA) kits are intended for cranial fixation during CT and and treatment with the Tomo Therapy Hi-Art system. Provides adapters for attaching: Integra head rings to the following: 1.Flat CT scanner tabletops ranging form 47cm to
| Date | Mar 8, 2012 (initiated Jan 23, 2012) |
| Status | Terminated |
| Reason | Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree TomoTherapy arc. |
| Root cause | Device Design |
| Action | Integra sent a Product Technical Bulletin dated January 23, 2012, to all affected consignees via FedEx, email or telephone conference calls. The revised Operator Manual was provided with a Technical Bulletin to all consignees that have been shipped this system. Consignees were asked to distribute the information in the bulletin to members of the Radiotherapy Planning Team within their institution. Customers were also asked to sign and return the enclosed Product Technical Bulletin Acknowledgement Form. For questions regarding this recall call 888-772-7378. |
| Quantity | 33 units |
| Distribution | Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS Integra Radionics, Inc., Oct 16, 2007 |