Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Reported: October 3, 2018 Initiated: July 16, 2018 #Z-3223-2018
Product Description
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Reason for Recall
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 5115 total
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, British Virgin Islands, Brazil, Brunei Darussalam, Blugaria, Cambodia, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominic Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea South, Republic of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, UAE, UK, Uzbekistan, Venezuela, Vietnam, and Yemen.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions. Recalled by Philips Electronics North America Corporation. Units affected: 5115 total.
Why was this product recalled? ▼
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2018. Severity: Moderate. Recall number: Z-3223-2018.
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