Z-0810-2016Class II

Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and...

Name: Z-0810-2016 Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and...
Creator: Philips Electronics North America Corporation
Published: 2015-07-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-07-06 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the... on 2015-07-06. FDA classified it as Class II and gives the reason as "The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0810-2016
Classification: Class II
Status: Terminated
Initiated: 2015-07-06
Posted: 2016-02-16
Terminated: 2017-02-03
Recalling firm: Philips North America LLC
Product: 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
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips sent a Field Safety Notice to all affected customers on July 6, 2015. The notice informs consignees of the reason for recall and actions to be taken by the customer/user. On September 15, 2015, Philips plans to issued a mandatory Field Safety Corrective action (FCO72200280) via Certified Return Receipt. This corrective action is the replacement of the affected MCS actuator. For further information, contact your local representative: Technical Support Line: 1-800-722-9377.
Quantity in commerce: 3158 devices
Distribution: 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.
Product codes and lots: Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-16

Product code IZI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)