The Recall Desk
HighFDA (Devices)·Z-3167-2024·Announced 2024-09-25

PHILIPS INTEGRIS X-ray systems cable hose carrier detachment recall

PHILIPS medical X-ray imaging systems may have a cable hose carrier that can detach due to broken plastic or bolts, potentially causing parts to fall and injure clinical staff.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving potential injury from mechanical failure (cable hose carrier detachment), but no reported illnesses or injuries have been documented. Per the severity rubric, recalls involving risk of harm where injury has not yet been reported score as High.

Plain-English summary

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling several models of INTEGRIS and Integris X-ray imaging systems used in hospitals and medical facilities.

The cable hose carrier on these systems may detach due to broken plastic components and/or bolts. If detachment occurs, parts of the cable assembly or the hose may fall, creating a potential hazard to clinical staff and risk of injury.

The recall affects approximately 250 units distributed nationwide, in Canada, and worldwide. All serial numbers of the following models are included: INTEGRIS Allura 15-12 (biplane, model 722044), Integris CV Cesar-Powerpack-Visub-Nicol (722030), INTEGRIS Allura 9 (biplane, 722021), Integris Allura 9 (722018), Integris H5000 F / Allura 9F (722017), and Integris H5000 C / Allura 9C (722016).

Facilities should contact the manufacturer for guidance on inspection, repair, or replacement of affected cable hose carriers.

The recalled product

Product
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — X-ray Imaging System
Hazard
Affected units
250

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · cable detachment

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