Z-1282-2021 Class II Terminated
FDA device recall Z-1282-2021 was initiated by Hitachi Medical Systems America Inc on March 1, 2021 and is designated Class II. Reason for recall: 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 conj… The recall status is terminated (terminated November 4, 2021). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- March 1, 2021
- Termination Date
- November 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of TX.
Code Information
Asset Tag: U8AR0479 Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2