Philips Allura Medical Imaging Systems Ceiling Mount May Fall
Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.
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 a Class II medical device recall involving a risk-of-harm product (ceiling-mounted component susceptible to falling in operating/imaging environments) where no injuries, deaths, or hospitalizations have been reported. The potential consequences are significant, but the hazard remains theoretical.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Allura ceiling-mounted imaging systems used for fluoroscopy and angiography procedures. The recalled systems include multiple model variants, ranging from model 722001 through 722043, including designations such as Allura Xper FD10, FD20, and Integris variants.
The ceiling-mounted L-arm contains a rotation cover that may become loose or fall if the arm collides with other hospital equipment such as operating lights. This condition could result in injury to personnel or compromise of the sterile environment in operating rooms and imaging suites.
The recalled systems have been distributed worldwide, including throughout the United States and in countries across Europe, Asia, Africa, and the Americas. Approximately 9,991 units are affected by this recall.
The recalled product
- Product
- Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allur
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- falling-component
- injury-risk
- contamination-risk
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 (14)
- Model/Name/UDI-DI: 722001 Allura Xper FD10C
- 722003 Allura Xper FD10
- 722006 Allura Xper FD20 (01)00884838059115(21)
- 722010 Allura Xper FD10 (01)00884838059030(21)
- 722012 Allura Xper FD20 (01)00884838059054(21)
- 722015 Allura Xper FD20 OR Table
- 722016 Integris H5000 C / Allura 9C
- 722018 Integris Allura 9
- - 722022 Allura Xper FD10 OR Table
- 722023 Allura Xper FD20 OR Table (01)00884838059085(21
- ) 722026 Allura Xper FD10 (01)00884838054189(21)
- 722028 Allura Xper FD20 (01)00884838054202(21)
- 722035 Allura Xper FD20 OR Table (01)00884838054240(21)
- 722043 Integris Allura 15 & 12 (monoplane).
Distribution
Distributed nationwide across the United States.
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