The Recall Desk
ModerateFDA (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.

What this means for you

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.
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

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