On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Boa
FDA device recall Z-1502-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
- Action taken
- Varian sent an Urgent Medical Device Correction letters March 20, 2014 to affected custoers via trackable mail. The letter was also distributed to Varian Sales, Marketing and Service organizations to inform them of the issues. The letter identified the affected product, description of problem, details, and recommended user actions to be taken. A Varian Customer Support Service representative will arrange a site visit to check the bel tension of the Type 01 elbow motors. If over tensioned belts are detected, the elbow motor will be replace with a Type O2 elbow motor. Questions may be directed to 888-827-4265.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 2622
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-03-20
- Date posted
- 2014-04-24
- Date terminated
- 2015-05-01
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ON-BOARD IMAGER DEVICE (K042720) | Varian Medical Systems | 2004-10-29 |