CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report
OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled
Carestream Health is recalling OnSight 3D Extremity System- X-Ray, Tomography Computed System, distributed nationwide in the US. The recall was initiated on 19 Mar 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-1207-2019
- FDA event ID
- 82491
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2019
- FDA classified
- 23 Apr 2019
- Reported
- 1 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 19 Mar 2019 | Recall initiated by company | |
| 23 Apr 2019 | Classified by FDA | +35 days |
| 1 May 2019 | 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
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
Product as listed by the FDA
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Where it was distributed
Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGDOM.
Nationwide AlabamaArizonaCaliforniaGeorgiaIllinoisMinnesotaNew YorkOregonPennsylvania
Questions about this recall
Why was it recalled?
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
Which lots are affected?
US Serial Numbers: 58008585 58007506 58000020 58008493 58000015 58007502 58007504 58008494 58007503 58008018 58007505 58008500 58008011 58008014 OUS: 10012 20005 20012 20016 20007 20017 10018 10004 10007 20004 20008 10023 10009 20019 20013 10002 10003 10014 10010 20006 20022 20003 20010
Where was it sold?
Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGDOM.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carestream Health
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|---|---|---|---|---|---|
| Device | CLASS II | DRX Revolution Mobile X-Ray System recalled by Carestream Health | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | The DRX-Revolution Mobile X-Ray System is a diagnostic recalled | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | Drx-Compass/Dr-fit X-ray Systems with Firmware recalled | Carestream Health | Other | Nationwide |
| Device | CLASS II | Kodak DirectView DR3000/3500 recalled by Carestream Health | Carestream Health | Other | IA |
| Device | CLASS II | DRX-Revolution Mobile X-Ray System recalled by Carestream Health | Carestream Health | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |