Recall Z-3217-2018— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-07-16, terminated 2022-11-18. It names one FDA 510(k) clearance: K031333. Product: INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions. 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..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-16
- Terminated
- 2022-11-18
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
INTEGRIS Allura 15-12 (biplane), System Code 722044 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.