CLASS II ONGOING Device recall · Reported 25 Mar 2026 · FDA Enforcement Report
Centricity Universal Viewer recalled by GE Medical Systems
GE Medical Systems is recalling Centricity Universal Viewer, distributed nationwide in the US. The recall was initiated on 30 Jan 2026 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-1570-2026
- FDA event ID
- 98428
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2026
- FDA classified
- 16 Mar 2026
- Reported
- 25 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 30 Jan 2026 | Recall initiated by company | |
| 16 Mar 2026 | Classified by FDA | +45 days |
| 25 Mar 2026 | 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
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
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
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Which lots are affected?
UDI Numbers: (01)00840682103800(10)6.0SP42094097001D (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)60P102.2094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP62094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.1.12094097001D 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Where was it sold?
Worldwide - 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.
Other products in this recall event
2 other products · FDA event 98428| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Universal Viewer recalled by GE Medical Systems | GE Medical Systems | Device Malfunction | Nationwide | |
| CLASS II | Centricity Universal Viewer recalled by GE Medical Systems | GE Medical Systems | Device Malfunction | Nationwide |
More recalls from GE Medical Systems
All 160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Giraffe OmniBed Field Replaceable Unit (FRU) recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 7 Pulse angiographic X-ray system recalled | GE Medical Systems | 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 |