BV26 Mobile X-Ray System
This recall has been terminated (originally issued September 15, 2004).
- Recall Initiated
- July 20, 2004
- Posted
- September 15, 2004
- Terminated
- February 9, 2006
- Recall Number
- Z-1455-04
- Quantity
- 1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for c-arm to move due to loose screws
Distribution
The units are distributed to hospitals and medical centers throughout the U.S.
Lot / Code Info
see site numbers listed above for BV 25
Root Cause
Other
Action Taken
Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.
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