Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-1979-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201

Product Classification:

Class II

Date Initiated: May 1, 2021

Date Posted: July 7, 2021

Recall Number: Z-1979-2021

Event ID: 87974

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.

Status: Ongoing

Product Quantity: 1,301 Monitor Bracket Assemblies total

Code Information:

Model/ Serial Number/UDI: 728120 2516 N/A 728120 3179 N/A 728120 3316 N/A 728201 9326 N/A 728120 3304 N/A 728120 3271 N/A 728120 2537 N/A 728120 3324 N/A 728120 H3321 N/A 728120 3058 N/A 728125 2529 N/A

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.

Voluntary or Mandated:

Voluntary: Firm initiated