Philips Allura X-Ray System Ceiling Suspension Recall
Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Philips Medical Systems, Inc. is recalling the INTEGRIS H5000F/Allura 9F X-ray imaging systems, model 722017. The recall is due to a defect in the monitor ceiling suspension system, which may fall.
The affected systems are intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostics and interventional procedures. The products were distributed worldwide, including in the United States, Canada, Australia, and several other countries.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not specify the number of units affected or report any injuries.
The recalled product
- Product
- Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- S/N: N/A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Philips Medical Systems, Inc. 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 9 products in this recall →Related recalls
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