FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
- Recall number
- Z-0330-2008
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
- Status
- Terminated
- Initiated
- 2007-09-24
- Posted
- 2007-12-07
- Terminated
- 2012-05-03
- Reason
- Inaccurate anatomical measurements when using the optional SmartMask feature
- Root cause
- Device Design
- Action
- The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.
- Quantity
- 53 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers affected: 18, 19, 22, 23, 24, 32, 33, 34, 36, 38, 52, 54, 56, 67, 68, 69, 71, 73, 74, 82, 84, 94, 99, 100, 102, 103, 106, 108, 112, 113, 116, 124, 125, 126, 131, 133, 141, 142, 148, 154, 157, 173, 174, 176, 178, 187, 191, 192, 197, 199, 212, and 691.
- 510(k) numbers
- ["K033737"]
- PMA numbers
- not on file
- Product code
- IZI
- 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