CLASS II Device recall · Reported 24 Feb 2016 · FDA Enforcement Report
Actuator for angiographic x-ray monitor ceiling suspension system recalled
Philips Electronics North America is recalling Actuator for angiographic x-ray monitor ceiling suspension system, distributed nationwide in the US. The recall was initiated on 6 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0810-2016
- FDA event ID
- 71647
- Recalling firm
- Philips Electronics North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2015
- FDA classified
- 16 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Jul 2015 | Recall initiated by company | |
| 16 Feb 2016 | Classified by FDA | +225 days |
| 24 Feb 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Product as listed by the FDA
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722015 Allura Xper FD20 OR Table; 722020 Allura Xper FD20 Biplane OR Table; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722035 Allura Xper FD20 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722123 Field extensions Xper cardio R7.6; 722124 Field extensions Xper vascular R7.6; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems R7.6; 72249 INTEGRIS BV5000; 722043 INTEGRIS Allura 15-12 (mono); 722121 Field extensions INTEGRIS cardio systems
Where it was distributed
Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Panama, PERU, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom and Viet Nam.
Questions about this recall
Is Actuator for angiographic x-ray monitor ceiling suspension system recalled?
Yes. Philips Electronics North America recalled Actuator for angiographic x-ray monitor ceiling suspension system on 6 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-0810-2016.
Why was it recalled?
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Which lots are affected?
Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122
Where was it sold?
Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Panama, PERU, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom and Viet Nam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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