Home / Recalls / Philips Electronics North America Corporation / Z-3213-2018

Z-3213-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

FDA device recall Z-3213-2018 was initiated by Philips Electronics North America Corporation on July 16, 2018 and is designated Class II. 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 Ceil… The recall status is terminated (terminated November 18, 2022). Affected quantity: 5115 total.

Recall Details

Product Type: Devices
Report Date: October 3, 2018
Initiation Date: July 16, 2018
Termination Date: November 18, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5115 total

Product Description

INTEGRIS Allura 9, System Code 722018 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.

Distribution Pattern

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.

Code Information

All systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected.

Other recalls by Philips Electronics North America Corporation

Z-0614-2019 Class II — Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6. (November 15, 2018)
Z-0592-2019 Class II — IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Pro (October 10, 2018)
Z-3235-2018 Class II — Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and (July 16, 2018)
Z-3232-2018 Class II — Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and n (July 16, 2018)
Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)
Z-3218-2018 Class II — INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascula (July 16, 2018)
Z-3239-2018 Class II — Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and (July 16, 2018)
Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
Z-3237-2018 Class II — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and ne (July 16, 2018)
Z-3228-2018 Class II — AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovasc (July 16, 2018)