Tustin, CA, United States
Toshiba American Medical Systems Inc recalls
2 recalls recorded since 2018, most recently on 4 January 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 January 2018
- Terminated
- 10 October 2023
- 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.
- Distribution
- USA (nationwide) Distribution 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2315-2018
- 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
Terminated Class II Medical devices
- Recall started
- 29 December 2017
- Terminated
- 29 November 2023
- Reason
- During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0843-2018, Z-0842-2018, Z-0845-2018, Z-0844-2018
- INFX-8000C Fluoroscopic X-Ray Systems
- INFX-8000F Fluoroscopic X-Ray Systems
- INFX-8000H Fluoroscopic X-Ray Systems
- INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.