# FDA recall Z-1981-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-05-01.

## Product

Continuous CT Fluoroscopy DVI Ceiling Mount   CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.    Brilliance 16 Power, Brilliance 16/10/6 Water/Air  728240/728245/728246 - Brilliance 16  728255/728256/728266 - Brilliance 6  728250/728251 - Brilliance 10  728260 - Extended Brilliance Workspace

## 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.

## 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.

## Key facts

- **Recall number:** Z-1981-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-01
- **Report date:** 2021-07-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1981-2021

## Citation

> AI Analytics. FDA recall Z-1981-2021. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1981-2021. Source: US FDA. Licensed CC0.

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