FDAFDA · Food and drugs·Recall number Z-0788-2019
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: 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).
Published February 6, 2019 · Recall initiated: December 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide distribution.
- Lot
- Serial Numbers: (a) Model BT09 130913SU7 127352SU3 130833SU7 130916SU0 125037SU2 116717SU0 130918SU6 131929SU2 127354SU9 126738SU4 106959SU0 114157SU1 115431SU9 115621SU5 106958SU2 116720SU4 121210SU9 130914SU5 130919SU4 132216SU3 113312SU3 130241SU3 111546SU8 120810SU7 112875SU0 123137SU2 112879SU2 112095SU5 113765SU2 115170SU3 117847SU4 128516SU2 103781SU1 131404SU6 125738SU5 120806SU5 120808SU1 127924SU9 128512SU1 128830SU7 128827SU3 130243SU9 106949SU1 122763SU6 111035SU2 111034SU5 112405SU6 106953SU3 110077SU5 113766SU0 106951SU7 116713SU9 122758SU6 127351SU5 130242SU1 111549SU2 126600SU6 126739SU2 112799SU2 123139SU8 121513SU6 123136SU4 128513SU9 131407SU9 123138SU0 122115SU9 118304SU5 132214SU8 132371SU6 106962SU4 123141SU4 113310SU7 115626SU4 113313SU1 121212SU5 126126SU2 111548SU4 132372SU4 121209SU1 130917SU8 128826SU5 122426SU0 127923SU1 113767SU8 106952SU5 112876SU8 131926SU8 126542SU0 128828SU1 120807SU3 114158SU9 112878SU4 131930SU0 132217SU1 130837SU8 114636SU4 130915SU2 132370SU8 125741SU9 127347SU3 122117SU5 126740SU0 122422SU9 118303SU7 115432SU7 115433SU5 132218SU9 121211SU7 122756SU0 122761SU0 125033SU1 120809SU9 115623SU1 127348SU1 122430SU2 116715SU4 116714SU7 106957SU4 115624SU9 130836SU0 112880SU0 130835SU2 114159SU7 131408SU7 131405SU3 120803SU2 121511SU0 121509SU4 114637SU2 115622SU3 125739SU3 125736SU9 125740SU1 106960SU8 122118SU3 125038SU0 127925SU6 110529SU5 122424SU5 125036SU4 126543SU8 115171SU1 130834SU5 112877SU6 116719SU6 125035SU6 121510SU2 112094SU8 106945SU9 122759SU4 126128SU8 122423SU7 116711SU3 131098SU6 131097SU8 131095SU2 131094SU5 122970SU7 126955SU4 120371SU0 126321SU9 131875SU7 107577SU9 109713SU8 128321SU7 130282SU7 127191SU5 106008SU6 126319SU3 107573SU8 120307SU4 122000SU3 119052SU9 119051SU1 121753SU8 124984SU6 124997SU8 126953SU9 116922SU6 130294SU2 124979SU6 109840SU9 128917SU2 118015SU7 118016SU5 118017SU3 118005SU8 118006SU6 118008SU2 118007SU4 118000SU9 117999SU3 118010SU8 117996SU9 118028SU0 118027SU2 118030SU6 118029SU8 118001SU7 118002SU5 118014SU0 118021SU5 118023SU1 118022SU3 118024SU9 118043SU9 118041SU3 118040SU5 118039SU7 118038SU9 118035SU5 118036SU3 118037SU1 118033SU0 118032SU2 118034SU8 118018SU1 118020SU7 118019SU9 118025SU6 118026SU4 118004SU1 118003SU3 119042SU0 123762SU7 126088SU4 128668SU1 130240SU5 116811SU1 128657SU4 127345SU7 128662SU4 128664SU0 128658SU2 116813SU7 123758SU5 116816SU0 125161SU0 115439SU2 121507SU8 126822SU6 121508SU6 123755SU1 127344SU0 116176SU9 116180SU1 115442SU6 115443SU4 116817SU8 127475SU2 127476SU0 127473SU7 127474SU5 115440SU0 116814SU5 126087SU6 123757SU7 116819SU4 128666SU5 127922SU3 116812SU9 128656SU6 128661SU6 119923SU1 116179SU3 116820SU2 123760SU1 123759SU3 123753SU6 123752SU8 123750SU2 126598SU2 127466SU1 127468SU7 127470SU3 127469SU5 130200SU9 130201SU7 122755SU2 123749SU4 126086SU8 116818SU6 116815SU2 126085SU0 123751SU0 123761SU9 123763SU5 116173SU6 126596SU6 126597SU4 116177SU7 128665SU7 126595SU8 116175SU1 123756SU9 123754SU4 127471SU1 127472SU9 128667SU3 128663SU2 128660SU8 116178SU5 116174SU4 127346SU5 107597SU7 130807SU1 124552SU1 124554SU7 120383SU5 124556SU2 124553SU9 129687SU0 122959SU0 124555SU4 121440SU2 122958SU2 120382SU7 130821SU2 130822SU0 130820SU4 129046SU9 127465SU3 125248SU5 128911SU5 129328SU1 123324SU6 121441SU0 129043SU6 129737SU3 119623SU7 124130SU6 111945SU2 117622SU1 116875SU6 120888SU3 123373SU3 129042SU8 118426SU6 126347SU4 125356SU6 128825SU7 115172SU9 111378SU6 111377SU8 121506SU0 129326SU5 128553SU5 128655SU8 121763SU7 109832SU6 116326SU0 124978SU8 130824SU6 109831SU8 122209SU0 128915SU6 128912SU3 115104SU2 119050SU3 132582SU8 11691
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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