GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Reported: March 18, 2015 Initiated: January 30, 2015 #Z-1248-2015
Product Description
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Reason for Recall
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
Details
- Recalling Firm
- GE Healthcare
- Units Affected
- 192 (131 US, 61 OUS).
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, IRELAND, ITALY, JAPAN, NEW ZEALAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, and UNITED KINGDOM.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.. Recalled by GE Healthcare. Units affected: 192 (131 US, 61 OUS)..
Why was this product recalled? ▼
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2015. Severity: Moderate. Recall number: Z-1248-2015.
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