Recall Z-3216-2018 ยท IZI System, X-Ray, Angiographic
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
| Date | Sep 21, 2018 (initiated Jul 16, 2018) |
| Status | Terminated |
| 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. - |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., May 13, 2003 |