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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system

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  Class 2 Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system see related information
Date Initiated by Firm August 29, 2008
Date Posting Updated January 05, 2009
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-0342-2009
Recall Event ID 50083
510(K)Number K073542  
Product Classification Fluoroscopic x-ray system - Product Code JAA
Product GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
Code Information -0324

ES-0325

ES-0327

ES-0328

ES-0329

ES-0330

ES-0331

ES-0333

ES-0334

ES-0338

ES-0339

ES-0340

ES-0341

ES-0344

ES-0345

ES-0346

ES-0347

ES-0348

ES-0350

ES-0353

ES-0356

ES-0357

ES-0361

ES-0362

ES-0368

ES-0369

ES-0370

ES-0371

ES-0372

ES-0373

ES-0386

ES-0388

ES-0389

ES-0392

ES-0393

ES-0395

ES-0396, ES-0397

ES-0398

ES-0406

ES-0407

ES-0408

ES-0409

ES-0410

ES-0411

ES-0414

ES-0416

ES-0420

ES-0424

ES-0426

ES-0432

ES-0440

ES-0447

ES-0448

ES-0449

ES-0453,, ES-0457,, ES-0466,, ES-0470,, ES-0471,, ES-0473,, ES-0474,, ES-0475,, ES-0477,, ES-0481,, ES-0489,, ES-0491,, ES-0492,, ES-0503

ES-0504,, ES-0505,, ES-0507,, ES-0508,, ES-0516

ES-0517,, ES-0519,, ES-0520,, ES-0530,, ES-0531,, ES-0537

ES-0540,, ES-0542,, ES-0543,, ES-0546,, ES-0548,, ES-7002-MH, and, ES-7029-MH..
Recalling Firm/
Manufacturer
OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact Deena Pease
801-536-4952
Manufacturer Reason
for Recall
Under certain conditions, x-ray system may experience operational impairment.
FDA Determined
Cause 2
Device Design
Action Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.
Quantity in Commerce 448 units
Distribution Nationwide, including AK, KY, NC, VA WA. and WI
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = PT PRODUCTS, LLC
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