CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report
MHI-TM2000 Linear Accelerator System recalled
Hitachi Ltd., Medical System Operations Group is recalling MHI-TM2000 Linear Accelerator System, distributed in New York. The recall was initiated on 8 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1585-2018
- FDA event ID
- 79439
- Recalling firm
- Hitachi Ltd., Medical System Operations Group, Kashiwa, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2017
- FDA classified
- 1 May 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 8 Dec 2017 | Recall initiated by company | |
| 1 May 2018 | Classified by FDA | +144 days |
| 9 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Where it was distributed
US Distribution in the state of NY.
Questions about this recall
Is MHI-TM2000 Linear Accelerator System recalled?
Yes. Hitachi Ltd., Medical System Operations Group recalled MHI-TM2000 Linear Accelerator System on 8 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1585-2018.
Why was it recalled?
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Which lots are affected?
Serial Number: 203919
Where was it sold?
US Distribution in the state of NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |