Reported Aug 21, 2013 · Terminated
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
- Lot codes and dates
- Mfg Lot or Serial #
755 of 755 codes
171947SU5176566SU8176567SU6179458SU5182385SU5182653SU6182654SU4182656SU9164236SU2173818SU6172242SU0172243SU8176260SU8180632SU2181231SU2181232SU0181233SU8181234SU6181235SU3158763SU3158799SU7159780SU6163222SU3165600SU8168075SU0169495SU9170681SU1170893SU2171937SU6171941SU8171943SU4176123SU8176125SU3176129SU5177080SU9178951SU0180108SU3180110SU9180763SU5180766SU8182661SU9182379SU8176132SU9159604SU8159766SU5158247SU7172656SU1161686SU1170273SU7170272SU9170274SU5176924SU9159768SU1170197SU8171541SU6171540SU8171542SU4164268SU5166218SU8171371SU8
- Mfg Lot or Serial #
- Amount recalled
- 755
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measur
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Healthcare, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.