FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Philips Multi Diagnost Eleva
- Recall number
- Z-0912-2007
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Philips Multi Diagnost Eleva
- Status
- Terminated
- Initiated
- 2007-07-23
- Posted
- 2007-09-25
- Terminated
- 2012-09-17
- Reason
- Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
- Root cause
- Other
- Action
- On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.
- Quantity
- 44 units
- Distribution
- Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
- Lot, serial or model codes
- Site numbers 103056, 104136, 521113 102666, 104083, 104530, 105193, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506155, 506236, 506247, 519574, 532087, 532140, 532151, 532213, 532703, 533312, 533473, 533559, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 538440, 539457, 539598, 539990, 540252, 541263, 541474
- 510(k) numbers
- ["K023441"]
- 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