FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
- Recall number
- Z-1657-2011
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
- Status
- Terminated
- Initiated
- 2010-10-07
- Posted
- 2011-03-16
- Terminated
- 2012-02-23
- Reason
- A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
- Root cause
- Nonconforming Material/Component
- Action
- On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
- Quantity
- 16 units distributed in US
- Distribution
- Devices were distributed through out the US.
- Lot, serial or model codes
- Site Numbers: 520020, 522220, 533112, 533314, 533471, 535257, 539106, 541490, 547017, 547348, 549798, 553676, 42036161, 42383151, 43180366, and 43680651.
- 510(k) numbers
- ["K032046"]
- 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