Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS...
FDA Device Recall #Z-0810-2016 — Class II — July 6, 2015
Recall Summary
| Recall Number | Z-0810-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 6, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Electronics North America Corporation |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 3158 devices |
Product Description
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
Reason for Recall
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Distribution Pattern
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.
Lot / Code Information
Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122
Other Recalls from Philips Electronics North America Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0614-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Softw... | Nov 15, 2018 |
| Z-0592-2019 | Class II | IntelliVue MX40 Patient Monitor, Model Nos. 865... | Oct 10, 2018 |
| Z-3227-2018 | Class II | Allura Xper F010, System Code 722003 Vascul... | Jul 16, 2018 |
| Z-3218-2018 | Class II | INTEGRIS SUITE, System Code 722199 Vascular... | Jul 16, 2018 |
| Z-3215-2018 | Class II | INTEGRIS CV, System Code 722030 Vascular, c... | Jul 16, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.