CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report
innova 3100-IQ, Mobile X-ray system The innova systems recalled
GE Healthcare is recalling innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in, distributed nationwide in the US. The recall was initiated on 20 Dec 2011 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-0114-2013
- FDA event ID
- 63027
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2011
- FDA classified
- 22 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 20 Dec 2011 | Recall initiated by company | |
| 22 Oct 2012 | Classified by FDA | +307 days |
| 31 Oct 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Where it was distributed
Nationwide distribution
Questions about this recall
Why was it recalled?
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
Which lots are affected?
Model number - 5892935G052G
Where was it sold?
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 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.
Other products in this recall event
2 other products · FDA event 63027| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | innova 3131-IQ Mobile X-ray system recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS II | innova 3100, Mobile X-ray system recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
More recalls from GE Healthcare
All 512| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Signa Premier systems recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity Universal Viewer Zero Footprint Client recalled | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled | GE Healthcare | Device Malfunction | |
| Device | CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
| Device | CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare | GE Healthcare | Other | IL |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |