RecallRadar

FDA Device recall Z-0022-2015

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

On 2014-10-15 the FDA classified a Class II recall of Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system by Philips Medical Systems, citing philips had discovered through a field service testing where a device failed to comply with a Federal standard.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0022-2015
ClassificationClass II
Statusterminated
Initiated2014-08-08
Published2014-10-15
Last updated2026-09-13 11:53 UTC
CompanyPhilips Medical Systems
DistributionFL

Product

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

Reason

Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

Identifiers

code_infoModel Number: Integris Allura 15-12 Serial Number: 16741023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.