Recall Z-1790-2012— General Electric Med Systems LLC
Class II · Terminated
Class II FDA medical device recall by General Electric Med Systems LLC, initiated 2006-05-31, terminated 2012-07-31. It names one FDA 510(k) clearance: K993090. Product: GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.. Reason: An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath.
- Recalling firm
- General Electric Med Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2006-05-31
- Terminated
- 2012-07-31
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated 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
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
Data sourced from openFDA. This site is unofficial and independent of the FDA.