Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Refere
FDA device recall Z-0945-2012 · posted 2012-02-03 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted.
- Action taken
- The firm, Varian Medical Systems, Inc., sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated November 10, 2011 to all affected users. The letter describes the product, description of problem, details, recommended actions and Varian's actions. Varian Service will contact customers to arrange installation, once modifications are available. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter also included special instructions for customers outside the USA and Canada. The customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems once they have read the document. If you require further clarification, feel fee to contact your local Varian Customer Support District or Regional Manager at: USA and Canada: 1-888-VARIANS (1-888-827-4265); Europe: +41 41 749 8844; or Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com; Latin America: soporte.al@varian.com or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 205 units***12-12-12 AMENDED TO: 213 units***
- Distribution
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Algeria, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Finland, France, Germany
- Date initiated
- 2011-11-10
- Date posted
- 2012-02-03
- Date terminated
- 2015-02-19
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM MLC -120 (K990085) | Varian Assoc., Inc. | 1999-02-08 |