Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling three INTEGRIS vascular 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where a component may fall, posing a significant risk of injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Philips Medical Systems, Inc. is recalling three units of the Philips Healthcare INTEGRIS vascular System, Model 722122. 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 units were distributed worldwide, including in the United States, Canada, Australia, and several other countries. The specific serial numbers affected are 1181, 1188, and 1189.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Consumers and patients should not use the affected equipment until the issue is resolved.
The recalled product
- Product
- Philips Healthcare INTEGRIS vascular System Model : 722122 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 and…
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 3
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: 1181 1188 1189
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.
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