The Recall Desk
ModerateFDA (Devices)·Z-2711-2017·Announced 2017-07-19

Toshiba APLIO 500 Ultrasound Systems Recalled for Incorrect Velocity Trace Values

Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.

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 illnesses or injuries. The hazard is a potential for incorrect data display, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported.

Plain-English summary

Toshiba American Medical Systems Inc. is recalling 307 units of the APLIO 500 TUS-A500 diagnostic ultrasound system. The recall is due to a software issue where the system may display an incorrect value in the ultrasound systems and workstations when the Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement.

The affected units were distributed nationwide. The recall notice lists specific serial numbers for the affected devices. No illnesses or injuries have been reported in the source text.

Healthcare facilities should check their inventory against the provided list of serial numbers. If a device is affected, the facility should contact Toshiba American Medical Systems Inc. for further instructions on how to resolve the issue.

The recalled product

Product
APLIO 500 TUS-A500 diagnostic ultrasound system
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
307

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)

  • Serial Numbers: AAC1652199
  • AAC1652200
  • AAC1652201
  • AAC1652202
  • AAC1652203
  • AAC1652204
  • AAC1652205
  • AAC1652206
  • AAC1652207
  • AAC1652208
  • AAC1662209
  • AAC1662210
  • AAC1662211
  • AAC1662212
  • AAC1662213
  • AAC1662214
  • AAC1662215
  • AAC1662216
  • AAC1662217
  • AAC1662218

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Toshiba American Medical Systems Inc

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Same hazard · incorrect data

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