Food, drugs, devices › GE Healthcare
Device recall: GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
FDA enforcement event 70063 is a device recall by GE Healthcare of Waukesha, WI, initiated 8 Dec 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 3 Feb 2016. Initiation: voluntary: firm initiated. GE Healthcare has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, Waukesha, WI.
Reason for recall
"GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported."
Distribution
"USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0954-2015 | GE Healthcare, Proteus XR/a with wall stand model number 600-0301. | 3096 (2486 US, 610 OUS). | Class II | Terminated | 21 Jan 2015 |
Context
Other enforcement events for GE Healthcare
All 44 events for GE Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.