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Terminated

Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

FDA Recall Z-3227-2018 · Posted 2018-09-21

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeIZI
Date Initiated2018-07-16
Date Terminated2022-11-18
Product Quantity5115 total

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.

Firm Action

The firm, BU IGT System, sent an "Urgent -Medical Device Correction" notification letter dated 07/16/2018 to customers. The letter describes the product, problem and actions to be taken. The letter instructs customers to do the following: In order to reduce the risk for patients, users and bystanders if this problem would reoccur, we recommend the following actions until the correction has been implemented. -Avoid unnecessary movements of the Monitor Ceiling Suspension. -For those movements that are necessary, avoid that the user, patient or bystander are in close proximity to the monitor. -When moving the Monitor Ceiling Suspension, ensure that no body partsof the staff or patient are underneath the monitor. -Do not move the monitor above the patient. Please ensure that all staff with access to the affected systems are informed of the content of this Medical Device Correction. All affected products will be corrected by means of a Field Change Order (FCO) free of charge. This FCO will be available mid-August. You will be contacted by our local Philips representative to schedule this corrective action. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722- 9377, 8am to 8pm (EST) Monday thru Friday.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041949ALLURA XPER FD10Philips Medical Systems North America Co. · 2004-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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