Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2090-2017·Announced 2017-05-24

Hitachi Arietta 70 Ultrasound System Recalled for Weak Arm Mounting Mechanism

Hitachi Medical Systems America Inc is recalling 77 Arietta 70 Ultrasound Systems because the arm mounting mechanism was insufficiently strong and required redesign.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Hitachi Medical Systems America Inc is recalling 77 units of the Arietta 70 Ultrasound System. The recall was initiated because the strength of the arm mounting mechanism was insufficient and had to be redesigned.

The affected devices are intended for use by trained personnel, such as doctors and sonographers, for diagnostic ultrasound evaluation. The units were distributed to the states of Arizona, California, Florida, Hawaii, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, and Texas.

No specific consumer actions are detailed in the source text beyond the recall notice. Facilities using these devices should verify their serial numbers against the provided list and contact the manufacturer for further instructions regarding the redesign of the arm mounting mechanism.

The recalled product

Product: Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Manufacturer: Hitachi Medical Systems America Inc
Category: Medical Device — Diagnostic Imaging
Hazard: structural-defect
Affected units: 77

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

203A5592
203A5593
203A5594
203A5595
203A5596
203A5599
203A5615
20A5622
203A5623
203A5624
203A5625
203A5626
203A563 l
203A5632
203A5633
203A5637
203A5643
203A5652
203A5661
203A5668

Distribution

Distributed in 18 states:

Same manufacturer · Hitachi Medical Systems America Inc

See all →

Severe
Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
FDA (Devices) · 2021-03-31
High
Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring
FDA (Devices) · 2020-02-26
High
Hitachi Scenaria CT System Recalled for Potential Cable Detachment
FDA (Devices) · 2019-11-13
High
Hitachi Scenaria CT System Recalled for Table Motion Hazard
FDA (Devices) · 2018-08-29
High
Hitachi Oasis MRI Systems Recalled for Exposed Belt Hazard
FDA (Devices) · 2018-07-25

Same hazard · structural defect