Z-1655-2011

Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185

Name: Z-1655-2011 Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185
Creator: Philips Medical Systems North America Co. Phillips
Published: 2010-10-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-10-07 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185 on 2010-10-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1655-2011
Status: Terminated
Initiated: 2010-10-07
Posted: 2011-03-16
Terminated: 2012-02-23
Recalling firm: Philips North America LLC
Product: Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 1078 units distributed in US (1102 +24-48=1078)
Distribution: Devices were distributed through out the US.
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49794485, 49794687, 49794702, 51324694, 51324699, 51324716, and 51324768.

Product code IZI

K984545Class IIRelease 2 of Philips Integris Series (V5000, Bv5000, H5000, Bh5000, Hm2000) SystemsPhilips Medical Systems North America, Inc. / cleared 1999-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)