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 54 cm 2. TomoTherapy Hi-Art system tabletop
FDA Recall Z-1187-2012 · Posted 2012-03-08
Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-01-23
Date Terminated2012-10-01
Product Quantity33 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.