Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
FDA Recall Z-1987-2021 · Posted None
Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2021-05-01
Reason for Recall
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the
cables resulting in patient, operator, bystander, or service person to serious injury.
Firm Action
Philips issued URGENT- Field Safety Notice Medical Device Correction letter on 5/1/21 FSN 72800751 and FSN 88200530 . 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 their CCT DVI Ceiling Mount Arm (the circled area in picture at theright) and observe that the safety clip is installed (as depicted in pictures below).
" When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm.
When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions:
stop using the suspension monitor clinically
move the monitor arm away from any person
call Philips Service for repairs.
Please acknowledge the receipt of this notice by completing, signing, and returning the form attached at the end of this communication to the indicated email address.
Philips will inspect systems via Field Change Order FCO 88200530. Systems failing the inspection will be corrected via Field Change Order FCO 882531
For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.