Z-0367-2007

Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier

Name: Z-0367-2007 Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier
Creator: Philips Medical Systems North America Co. Phillips
Published: 2006-12-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-12-14 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier on 2006-12-14. The reason FDA records is "Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0367-2007
Status: Terminated
Initiated: 2006-12-14
Posted: 2007-01-25
Terminated: 2011-10-14
Recalling firm: Philips North America LLC
Product: Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
FDA root cause: Other
Action: On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.
Quantity in commerce: 140 devices total
Distribution: Units were distributed to hospitals and medical centers nationwide.
Product codes and lots: site numbers provided in the product listing for Z-0366-2007

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)