Company: GE Healthcare.
Date of Enforcement Report 1/19/2011
Class ll:
PRODUCT
1) HiSpeed LXI (2200997). Recall # Z-0744-2011;
2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011;
3) HiSpeed DX/I (2201000). Z-0746-2011;
4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011;
5) HiSpeed DX/I (2249696). Recall # Z-0768-2011;
6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011;
7) HiSpeed FX/I (2200997 with Gantry mo. #2200997). Recall # Z-0771-2011;
8) HiSpeed FX/I (2200997 with Gantry mo. #2201000). Recall # Z-0772-2011;
9) HiSpeed FX/I (2200997 with Gantry mo. #2200997-2). Recall # Z-0773-2011;
10) HiSpeed FX/I (2200997 with Gantry mo. #2201000-2). Recall # Z-0774-2011;
11) HiSpeed FX/I (2200997 with Gantry mo. #2249696). Recall # Z-0775-2011;
12) HiSpeed FX/I (2200997 with Gantry mo. #2249696-2). Recall # Z-0776-2011;
13) HiSpeed FX/I (2200997-2 with Gantry mo. #2200997). Recall # Z-0777-2011;
14) HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2). Recall # Z-0778-2011;
15) HiSpeed FX/I (2200997-2 with Gantry mo. #2201000). Recall # Z-0779-2011;
16) HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2). Recall # Z-0780-2011;
17) HiSpeed FX/I (2200997-2 with Gantry mo. #2249696). Recall # Z-0781-2011;
18) HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2). Recall # Z-0782-2011;
19) HiSpeed FX/I (2201000-2 with Gantry mo. #2200997). Recall # Z-0783-2011;
20) HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2). Recall # Z-0784-2011;
21) HiSpeed FX/I (2201000-2 with Gantry mo. #2201000). Recall # Z-0785-2011;
22) HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2). Recall # Z-0786-2011;
23) HiSpeed FX/I (2201000-2 with Gantry mo. #2249696). Recall # Z-0787-2011;
24) HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2). Recall # Z-0788-2011
REASON
A defect with the hardware and software displaying the incorrect dose data.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter on February 1, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
102
DISTRIBUTION
Nationwide
