RecallRadar

FDA Device recall Z-2315-2018

Diagnostic Ultrasound System, Aplio I-series

On 2018-07-04 the FDA classified a Class II recall of Diagnostic Ultrasound System, Aplio I-series by Toshiba American Medical Systems, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2315-2018
ClassificationClass II
Statusterminated
Initiated2018-01-04
Published2018-07-04
Last updated2026-09-13 11:54 UTC
CompanyToshiba American Medical Systems
DistributionUS

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.

Reason

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.

Identifiers

code_info
Model No. TUS-AI700. TUS-AI800, TUS-AI900. Serial No. HNA1792011, HAB1732009, HNA1772007, HNA1772006, HAB1732023, HAB1…Model No. TUS-AI700. TUS-AI800, TUS-AI900. Serial No. HNA1792011, HAB1732009, HNA1772007, HNA1772006, HAB1732023, HAB1732013, HAB1732016, HAB16Z2002, NJC17X2086, NJC17X2087, JHA16X2004, HAB1732027, HAB16Z2001, HAB16Z2002, NJB1762003, JHA1752022, HAB16Z2003, HAB16Z2004, JHA1752019, NJB1782050, HAB1742033, NJB1772031, HNA1792013, HNA1772008, JHA1752010, HAB1742035, HAB1742036, NJB1762001, NJB1782042, JHA1762034, HAB1732030, HAB16Z2005, HAB1732007, HAB1742034, HAB1742037, JHA1752024, NJB1772019, JHA1762029, JHA1762031, NJB1782061, HAB1732019, HNA1772001, HAB1712008, HAB1722011, HAB1712010, HAB1712009, HNA1792014, HAB1722012, HAB16Z2003, HAB1732017, HAB1732018, HAB1712006, HAB1732014, HAB1712007, HAB1732015, HAB1732021, HAB1732020, HAB1732025, JHA1762030, HAB1732029, HAB1732031, NJC17X2066, HNA1772002, NJB1782060, NJB1782043, NJB1762002, JHA16X2002, NJB1782057, NJB1782055, JHA1752021, NJB1782058, NJB1762006, NJB1782056, NJC17X2089, NJB1772023, NJB1782051, NJB1782052, NJB1782053, NJB178205

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2315-2018%22

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