CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Imagecast Pacs with Centricity Ris-ic versions prior recalled
Ge Healthcare It is recalling Imagecast Pacs with Centricity Ris-ic versions prior to 10.6 Update Package 18, distributed nationwide in the US. The recall was initiated on 18 Feb 2013 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-2300-2016
- FDA event ID
- 64758
- Recalling firm
- Ge Healthcare It, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Feb 2013
- FDA classified
- 28 Jul 2016
- Reported
- 3 Aug 2016
- Type
- N/A
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 18 Feb 2013 | Recall initiated by company | |
| 28 Jul 2016 | Classified by FDA | +1256 days |
| 3 Aug 2016 | 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
A software defect was discovered that causes images to be out of context with clinical information.
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
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Why was it recalled?
A software defect was discovered that causes images to be out of context with clinical information.
Which lots are affected?
Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.
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 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 Ge Healthcare It
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Centricity Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
| Device | CLASS II | Centricity Laboratory Core Lab System 4.1 The Centricity recalled | GE Healthcare It | Device Malfunction | 6 states |
| Device | CLASS II | GE Centricity PACS Workstation recalled by GE Healthcare It | GE Healthcare It | Other | Nationwide |
| Device | CLASS II | Centricity Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
| Device | CLASS III | The Centricity Laboratory System is intended to be recalled | GE Healthcare It | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
All 2,349| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xact mole marker for mammography recalled by Solstice | Solstice | Other | Nationwide |
| Device | CLASS I | Philips Lumify Diagnostic Ultrasound System recalled | Philips Ultrasound | Other | 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 |