Reported Feb 6, 2019 · Terminated
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The…
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 P6 Premium
- TruScan(TM) Imagining Technology(a)
- Model BT09 (b) Model BT07 Product UsageThe 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)
- Lot codes and dates
- Serial Numbers(a) Model(b) Model
1,284 of 1,284 codes
BT09130913SU7127352SU3130833SU7130916SU0125037SU2116717SU0130918SU6131929SU2127354SU9126738SU4106959SU0114157SU1115431SU9115621SU5106958SU2116720SU4121210SU9130914SU5130919SU4132216SU3113312SU3130241SU3111546SU8120810SU7112875SU0123137SU2112879SU2112095SU5113765SU2115170SU3117847SU4128516SU2103781SU1131404SU6125738SU5120806SU5120808SU1127924SU9128512SU1128830SU7128827SU3130243SU9106949SU1122763SU6111035SU2111034SU5112405SU6106953SU3110077SU5113766SU0106951SU7116713SU9122758SU6127351SU5130242SU1111549SU2126600SU6126739SU2112799SU2
561 of 561 codes
BT0794556SU890596SU881762SU785646SU892596SU690591SU9107938SU399377SU485645SU090594SU392253SU499376SU685647SU692595SU8105403SU094457SU998631SU599360SU090595SU088419SU791019SU084532SU185644SU388422SU188420SU592254SU285830SU890589SU398630SU788421SU399568SU897179SU690587SU790597SU6099566SU2099567SU084553SU798343SU798342SU994456SU197104SU499358SU494455SU392598SU299378SU294454SU694555SU081763SU5106063SU197103SU699359SU288423SU9105799SU191894SU697776SU9102764SU892189SU083725SU297099SU6
- Serial Numbers(a) Model
- Amount recalled
- 1,897 units
Why it was recalled
Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
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.
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