FDA Device recall Z-2221-2012

GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy

FDA Device
Class II
terminated
Published 2012-08-29

On 2012-08-29 the FDA classified a Class II recall of GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy by Ge Oec Medical Systems, citing X-ray units did not meet manufacturer's specification for linearity.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2221-2012
Classification	Class II
Status	terminated
Initiated	2007-10-19
Published	2012-08-29
Last updated	2026-09-13 11:53 UTC
Company	Ge Oec Medical Systems
Distribution	n/a

Product

GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

Reason

X-ray units did not meet manufacturer's specification for linearity.

Identifiers

code_info	Serial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939… Serial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939PU7, 3095PU7, 3103PU9, 3107PU0, 3219PU3, 3223PU5, 3224PU3, 3230PU0, 3233PU4, 3236PU7, 3358PU9, 3368PU8, 3500PU6, 3513PU9, 3514PU6, 3516PU2, 3523PU8, 3562PU6, 3580PU8, 3957PU8, 3973PU5, 3978PU4, 3994PU1, 4012PU1, 4018PU8, 4025PU3, 4029PU5, 4041PU0, 4043PU6, 4378PU6, 4394PU3, 4397PU6, 4446PU1, 4458PU6, 4767PU0, 4777PU9, 4782PU9, 4787PU8, 4793PU6, 4795PU1, 4797PU7, 4799PU3, 4800PU9, 4803PU3, 4806PU6, 4812PU4, 4813PU2, 4815PU7, 4818PU1, 4822PU3, 4827PU2, 4829PU8, 4830PU6, 4831PU4, 4835PU5, 4839PU7, 4840PU5, 4843PU9, 4844PU7, 4846PU2, 4847PU0, 4852PU0, 4853PU8, 5167PU2, 5169PU8, 5177PU1, 5179PU7, 5182PU1, 5188PU8, 5205PU0, 5208PU4, 5209PU2, 5211PU8, 5213PU4, 5216PU7, 5217PU5, 5219PU1, 5222PU5, 5224PU1, 5225PU8, 5227PU4, 5231PU6, 5233PU2, 5235PU7, 5236PU5, 5237PU3, 5239PU9, 5242PU3, 5244PU9, 5245PU6, 5246PU4, 5247PU2, 5249PU8, 5251PU4, 5260PU5, 5600PU2, 5602PU8, 5608PU5, 561

code_info

Serial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939…

Serial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939PU7, 3095PU7, 3103PU9, 3107PU0, 3219PU3, 3223PU5, 3224PU3, 3230PU0, 3233PU4, 3236PU7, 3358PU9, 3368PU8, 3500PU6, 3513PU9, 3514PU6, 3516PU2, 3523PU8, 3562PU6, 3580PU8, 3957PU8, 3973PU5, 3978PU4, 3994PU1, 4012PU1, 4018PU8, 4025PU3, 4029PU5, 4041PU0, 4043PU6, 4378PU6, 4394PU3, 4397PU6, 4446PU1, 4458PU6, 4767PU0, 4777PU9, 4782PU9, 4787PU8, 4793PU6, 4795PU1, 4797PU7, 4799PU3, 4800PU9, 4803PU3, 4806PU6, 4812PU4, 4813PU2, 4815PU7, 4818PU1, 4822PU3, 4827PU2, 4829PU8, 4830PU6, 4831PU4, 4835PU5, 4839PU7, 4840PU5, 4843PU9, 4844PU7, 4846PU2, 4847PU0, 4852PU0, 4853PU8, 5167PU2, 5169PU8, 5177PU1, 5179PU7, 5182PU1, 5188PU8, 5205PU0, 5208PU4, 5209PU2, 5211PU8, 5213PU4, 5216PU7, 5217PU5, 5219PU1, 5222PU5, 5224PU1, 5225PU8, 5227PU4, 5231PU6, 5233PU2, 5235PU7, 5236PU5, 5237PU3, 5239PU9, 5242PU3, 5244PU9, 5245PU6, 5246PU4, 5247PU2, 5249PU8, 5251PU4, 5260PU5, 5600PU2, 5602PU8, 5608PU5, 561

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2221-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.