Philips Electronics North America Corporation: Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Recall number

Z-3223-2018

Recalling firm

Philips Electronics North America Corporation

Product

Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Status

Terminated

Initiated

2018-07-16

Posted

2018-09-21

Terminated

2022-11-18

Reason

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.

Root cause

Device Design

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.

Quantity

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.

Lot, serial or model codes

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

510(k) numbers

["K033737"]

PMA numbers

not on file

Product code

IZI

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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