Recall Z-0281-2022 ยท KPS System, Tomography, Computed, Emission
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
| Date | May 1, 2021 |
| Status | Open, Classified |
| Reason | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part |
| Root cause | Device Design |
| Action | Philips notified U.S. consignees by "URGENT - Field Safety Notice Medical Device Correction" FSN 72800751 for CT consignees and FSN 88200530 for PET/CT consignees via USPS Certified mail on 5/1/21. Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Letter states reason for recall, health risk and action to take: Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of your CCT DVI Ceiling Mount Arm (the circled area in pic |
| Quantity | 4 units |
| Distribution | US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |