Recall Z-1188-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-07-25, terminated 2014-02-04. It names 5 FDA 510(k) clearances: K081496, K081105, K040372 and 2 more. Product: GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.. Reason: Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe.
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-07-25
- Terminated
- 2014-02-04
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K081496 — OPTIMA PET/CT 560
- K081105 — GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
- K040372 — LIGHTSPEED 7.0 CT SCANNER SYSTEM
- K030420 — LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
- K013561 — LIGHTSPEED 4.0 CT SCANNER SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Reason for recall
Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe
Data sourced from openFDA. This site is unofficial and independent of the FDA.