Recall Z-2801-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2015-07-17, terminated 2016-03-08. It names 3 FDA 510(k) clearances: K040172, K030420, K013561. Product: Lightspeed 16 CT. Reason: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-17
- Terminated
- 2016-03-08
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K040172 — MODIFICATION TO GE DISCOVERY LS 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
Lightspeed 16 CT
Reason for recall
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
Data sourced from openFDA. This site is unofficial and independent of the FDA.