FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

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Products

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
Brand
Integra LifeSciences Corp
UPC
Lot Number: 113820 114121 114430 114586 117771 121402 130169 131122 133760 133810 135008 135429 135429 141074 141563 143905 143905 148028 154133 155785 161426 166069 168862 172321 172321 182007 186253 189940 195330 195330 237711 2 units no lot number identified

Units Affected

33 units

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