FDA recall Z-2733-2024

Product

GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

Reason for recall

The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-07-12

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beijing, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2733-2024