Recall Z-2383-2012— Varian Medical Systems, Inc. Oncology Systems
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2012-08-14, terminated 2013-12-04. It names 2 FDA 510(k) clearances: K081188, K926321. Product: Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.. Reason: Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume..
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-14
- Terminated
- 2013-12-04
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K081188 — TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
- K926321 — VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.
Data sourced from openFDA. This site is unofficial and independent of the FDA.