The Recall Desk
ModerateFDA (Devices)·Z-2315-2018·Announced 2018-07-04

Toshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect

Toshiba is recalling 162 Aplio I-series diagnostic ultrasound systems because the power supply unit may be damaged and fail to start up.

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 describes a functional failure (failure to start up) without reporting any injuries, deaths, or significant property damage, fitting the criteria for a moderate severity recall.

Plain-English summary

Toshiba American Medical Systems Inc is recalling 162 units of the Aplio I-series Diagnostic Ultrasound System, labeled as i700, i800, and i900. The affected models are TUS-AI700, TUS-AI800, and TUS-AI900.

The recall is due to a defect where the power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON. The agency has classified this recall as Class II.

The affected units were distributed nationwide in the United States to the states of CA, CO, DE, GA, HI, IA, ID, IL, IN, MD, MI, MN, MO, NC, ND, NV, OH, OR, PA, SC, SD, TN, TX, VA, WA, WV, and WY. Specific serial numbers are listed in the official recall documentation.

The recalled product

Product
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Affected units
162

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)

  • Model No. TUS-AI700. TUS-AI800
  • TUS-AI900. Serial No. HNA1792011
  • HAB1732009
  • HNA1772007
  • HNA1772006
  • HAB1732023
  • HAB1732013
  • HAB1732016
  • HAB16Z2002
  • NJC17X2086
  • NJC17X2087
  • JHA16X2004
  • HAB1732027
  • HAB16Z2001
  • NJB1762003
  • JHA1752022
  • HAB16Z2003
  • HAB16Z2004
  • JHA1752019
  • NJB1782050

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically: