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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall GE OEC 9900 Elite ESP 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-0341-2009
Recall Event ID 50083
510(K)Number K073542  
Product Classification Fluoroscopic x-ray system - Product Code JAA
Product GE OEC 9900 Elite ESP 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 E9-0447

E9-0448

E9-0449

E9-0450

E9-0452

E9-0456

E9-0457

E9-0458

E9-0459

E9-0461

E9-0463

E9-0464

E9-0465

E9-0466

E9-0471

E9-0472

E9-0474

E9-0475

E9-0477

E9-0479

E9-0481

E9-0482

E9-0483

E9-0486

E9-0488

E9-0492

E9-0494

E9-0495

E9-0497

E9-0499

E9-0501

E9-0502

E9-0511

E9-0513

E9-0515

E9-0516

E9-0524

E9-0530

E9-0532

E9-0533

E9-0540

E9-0541

E9-0542

E9-0543

E9-0545

E9-0551

E9-0554, and, E9-0557

, ES-0013-G

ES-0019

ES-0050

ES-0054

ES-0103

ES-0110

ES-0113

ES-0114

ES-0115,, ES-0117

ES-0118

ES-0130

ES-0134

ES-0160

ES-0176

ES-0180, ES-0188

ES-0189

ES-0192

ES-0198

ES-0199

ES-0203

ES-0206

ES-0207

ES-0211

ES-0216

ES-0217

ES-0218

ES-0219

ES-0220

ES-0224

ES-0225

ES-0226

ES-0227

ES-0228

ES-0234

ES-0236

ES-0238

ES-0239

ES-0253

ES-0254

ES-0255

ES-0262

ES-0266

ES-0272

ES-0273

ES-0274

ES-0275

ES-0279

ES-0280

ES-0281, ES-0292

ES-0299

ES-0300

ES-0312

ES-0316

ES-0321

ES-0322

ES-0326, ES-0332

ES-0335

ES-0336

ES-0337

ES-0342

ES-0343,, ES-0349,, ES-0351, , ES-0352

ES-0354

ES-0355, ES-0358

ES-0359

ES-0360

ES-0363

ES-0364

ES-0365

ES-0366

ES-0367

ES-0374

ES-0375

ES-0376

ES-0377

ES-0378

ES-0379, ES-0380

ES-0381

ES-0382

ES-0383

ES-0384

ES-0385

ES-0387

ES-0390

ES-0391

ES-0394

ES-0396

ES-0399

ES-0400

ES-0401

ES-0402

ES-0403

ES-0404

ES-0405

ES-0412

ES-0413

ES-0415

ES-0417

ES-0418

ES-0419

ES-0421

ES-0422

ES-0423

ES-0425

ES-0427

ES-0428

ES-0429

ES-0430

ES-0431

ES-0433

ES-0434

ES-0435

ES-0436

ES-0437

ES-0438

ES-0439

ES-0441

ES-0442

ES-0443

ES-0444

ES-0445

ES-0446

ES-0450

ES-0451

ES-0452

ES-0454

ES-0455

ES-0458

ES-0459

ES-0460

ES-0462

ES-0463

ES-0464

ES-0465

ES-0467

ES-0468

ES-0469

ES-0472

ES-0476

ES-0478

ES-0479

ES-0480

ES-0482

ES-0483

ES-0484

ES-0485

ES-0486

ES-0487

ES-0488

ES-0490

ES-0493

ES-0494

ES-0495

ES-0496

ES-0497

ES-0498

ES-0499

ES-0500

ES-0501

ES-0502

ES-0509

ES-0510

ES-0513

ES-0514

ES-0515

ES-0518

ES-0521

ES-0522

ES-0523

ES-0526

ES-0527

ES-0528,, ES-0529

ES-0532

ES-0533,, ES-0536

ES-0538

ES-0544

ES-0547

ES-0549

ES-0552

ES-0553, and, ES-0561. ,
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 606 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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