FDA Device recall 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 us…

FDA Device
Class II
terminated
Published 2019-02-06

On 2019-02-06 the FDA classified a Class II recall of GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for us… by Ge Healthcare, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0788-2019
Classification	Class II
Status	terminated
Initiated	2018-12-28
Published	2019-02-06
Last updated	2026-09-13 11:55 UTC
Company	Ge Healthcare
Distribution	n/a

Product

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).

Reason

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.

Identifiers

code_info	Serial Numbers: (a) Model BT09 130913SU7 127352SU3 130833SU7 130916SU0 125037SU2 116717SU0 130918SU6 131929S… 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 126542SU

code_info

Serial Numbers: (a) Model BT09 130913SU7 127352SU3 130833SU7 130916SU0 125037SU2 116717SU0 130918SU6 131929S…

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 126542SU

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0788-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.