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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Rxi

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 Class 2 Recall
Precision Rxi
see related information
Date Posted August 24, 2008
Recall Status1 Open
Recall Number Z-1563-2008
Recall Event ID 46807
Premarket Notification
510(K) Number
K041605 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of exams for various clinical applications with ether 23 cm image intensifier with 512x512 Image Chain or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image Chain.
Code Information 101 103 117 121 128 132 133 135 136 152 156 160 162 164 173 178 182 184 190 194 196 201 202 209 221 228 232 235 238 240 246 250 251 252 254 259 260 261 263 264 267 268 273 275 276 281 283 289 295 297 300 302 310 322 330 331 333 342 343 347 348 351 353 354 365 367
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System. .
FDA Determined
Cause 2
DESIGN: Device Design
Action Two letters "GE Product Safety Notification" dated 12/18/07 and 3/7/08, addressed to Hospital Administrators, Manager of Radiology and Radiologists, were sent to each consignee. Each letter addressed a separate safety issue. Letters described the affected product, safety instructions, corrective action and contact information. The joystick can become stuck causing unintentional motion of the tube. Field Modification Instructions (FMI 10802/10803) have been issued to the field to install additional warning labels on the patient table, install a protector for the console joystick and inspect and correct the clearance between the console joystick and its mounting location. If your facility has a Precision RXi or Precision e system manufactured before March 2007, a GE Healthcare Field Engineer will schedule a field visit to install the added joystick protection. This upgrade will be performed at no charge. If you have any questions/concerns regarding this issue, please contact your local GE Healthcare sales or service representative.
Quantity in Commerce 66
Distribution (USA) AK CO IL LA MA MI MS NC NJ NY PA SC TN UT VA WA WI (OUSA) BR CA MX AU C3 KR PH TW AE AT BE BF BG CM CY CZ DE ES FI FR GB GE GR GY HR HU IT LB LV MT NA NG PL PT RO RU SA SD SE SI SK SY TN TR UA YU ZA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GENERAL MEDICAL MERATE S.P.A.
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