FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: View Forum 2003 software, SW 3.4L1
- Recall number
- Z-0896-05
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- View Forum 2003 software, SW 3.4L1
- Status
- Terminated
- Initiated
- 2005-04-29
- Posted
- 2005-06-16
- Terminated
- 2008-05-09
- Reason
- Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
- Root cause
- Other
- Action
- On 4/29/05 the firm mailed a letter, via certified return receipt. to their customers. The letter notified users of the problem and offered a work around. Consignees were advised they would be contacted by a representative to upgrade the unit with new software.
- Quantity
- 18 units
- Distribution
- The units were distributed to 18 medical centers thorughout the US.
- Lot, serial or model codes
- The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053
- 510(k) numbers
- ["K032096"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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
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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