Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI… recallZ-1983-2021 · Philips North America Llc · initiated May 1, 2021

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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).

Recall details

Recall number

Z-1983-2021

Status

Open, Classified

Initiated by the company

May 1, 2021

Recalling firm

Philips North America Llc

Quantity

1,301 Monitor Bracket Assemblies total

Product code

JAK

FDA submissions

K033357

Distribution

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.

Product description

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Brilliance CT Big Bore

  Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
  7 recalls1 report
• Big Bore RT

  Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
  4 recalls1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 87974).

• Z-1982-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728…
• Z-1984-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 12…
• Z-1985-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
• Z-1986-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
• Z-1987-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
• Z-1988-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
• Z-1990-2021 · Open, Classified
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP