Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws
Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.
What this means for you
Illness, injury, or structural failure has been reported. 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 that could cause uncontrolled movement, posing a significant injury risk, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
Philips Electronics North America Corporation is recalling two units of the Allura Xper FD20/15 R8.2 722058 medical device. These systems are intended for cardiovascular and vascular X-ray imaging applications, including diagnostic and interventional procedures such as PTCA, stent placement, atherectomies, pacemaker implantations, and Electro Physiology (EP).
The recall is due to a production error where screws were not tightened to the specified torque. This defect may cause the screws to come loose from the C-arm shaft, which could result in the C-arm rotating in an uncontrolled manner.
The affected units were distributed in the United States (Washington) and internationally in China, Spain, Korea, Republic of, and Germany. Users of these devices should contact Philips for further instructions regarding the recall.
The recalled product
- Product
- Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 2
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 (2)
- 159
- 183
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Philips Electronics North America Corporation 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 Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · uncontrolled movement
See all →- HighRebstock Holding Rod for Fixation May Move Uncontrollably
FDA (Devices) · 2024-03-06
- HighSkytron GS70H Surgical Table Recall: Control Failure Causes Continued Movement
FDA (Devices) · 2023-09-06
- HighX-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure
FDA (Devices) · 2023-06-07
- HighMedical Device Recall: X-Ray Detector Drive Shaft May Break
FDA (Devices) · 2023-06-07
- Highda Vinci Surgical System Patient Cart Ballscrew Failure Risk
FDA (Devices) · 2023-03-22