Hitachi Medical Systems America Inc Recall 87493
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.
Hitachi Medical Systems America Inc Recall 87493 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1282-2021 |
| Event ID | 87493 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of TX. |
| Quantity | 1 |
| Recall 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. |
| Device Classification | 20210331 |
| Device Code Info | Asset Tag: U8AR0479 Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 |
| Center Classification Date | 20210319 |
| Recall Initiation Date | 20210301 |
| Recalling Firm | Hitachi Medical Systems America Inc |
| Initial Notification | Letter |
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