Device product
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.
Z-1282-2021
Product summary
- Event
- Event 87493
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1282-2021
Official wording
Reason: Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.
Code information: Asset Tag: U8AR0479 Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2
Distribution pattern: US Nationwide distribution in the state of TX.
Derived failure modes
-
Device software or design
software version 4.0.0., 4.0.1, and 4.0.2 has an error
-
Potency or specification failure
out of specification