FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: BV212 Mobile X-Ray System
- Recall number
- Z-1457-04
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- BV212 Mobile X-Ray System
- Status
- Terminated
- Initiated
- 2004-07-20
- Posted
- 2004-09-15
- Terminated
- 2006-02-09
- Reason
- Potential for c-arm to move due to loose screws
- Root cause
- Other
- Action
- 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.
- Quantity
- 1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212
- Distribution
- The units are distributed to hospitals and medical centers throughout the U.S.
- Lot, serial or model codes
- see site numbers listed above for BV 25
- 510(k) numbers
- ["K910115"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28