CLASS II Device recall · Reported 27 Mar 2019 · FDA Enforcement Report
Fujifilm FDR Go PLUS, Mobile X-Ray System recalled
Fujifilm Medical Systems U.S.A is recalling Fujifilm FDR Go PLUS, Mobile X-Ray System, distributed nationwide in the US. The recall was initiated on 15 Jan 2019 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-1040-2019
- FDA event ID
- 82187
- Recalling firm
- Fujifilm Medical Systems U.S.A, Lexington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2019
- FDA classified
- 21 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 15 Jan 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +65 days |
| 27 Mar 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
Product as listed by the FDA
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Fujifilm FDR Go PLUS, Mobile X-Ray System recalled?
Yes. Fujifilm Medical Systems U.S.A recalled Fujifilm FDR Go PLUS, Mobile X-Ray System on 15 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-1040-2019.
Why was it recalled?
FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
Which lots are affected?
Serial Numbers: MQ0001281001 through MQ0001285004
Where was it sold?
US Nationwide Distribution
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.
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|---|---|---|---|---|---|
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