Device Recall Olympus

Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07

General and Plastic Surgery Devices

2

No

nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe

Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)

All lot numbers of Pediatric knives: Model numbers A37008A, A37009A, A37010A and Pediatric HF resection electrodes: Model numbers A37011A, A37012A, A37013A.

Gastroenterology-Urology Devices

2

No

USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI.

OLYMPUS Pediatric Knives and Resection Electrodes || The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.

Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.

Not Classified

No

Nationwide Distribution.

Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. || Mobile X-ray System.

Serial numbers 622483, 622523, 622553, 622566, 622568, 622569, 622573, 622576, 622614, 622615, 622616, 622617, 622618, 622619, 622620, 622632, 622643, 622644, 622645, 622646, 622647, 622654, 622655, 622656, 622657, 622658, 622664, 622666, 622667, 622687, 622688, 622693, 622704, 622705, 622706, 622710, 622711, 622712, 622718, 622719, 622720, 622722, 622723, 622750, 622753, 622764, 622766, 622767, 622769, 622771, 622773, 622775, 622777, 622778, 622785, 622789, 622795, 622797, 622798, 622801, 622806, 623624, 623626, 623629, 623637, 623638, 623639, 623641, 623661, 623669, 623671, 623672, 623673, 623677, 623687, 623688, 623705, 623709, 623713, 623719, 623720, 623722, 623723, 623729, 623730, 623731, 623735, 623736, 623737, 623738, 623739, 623740, 623741, 623742, 623743, 623747, 623749, 623750, 623751, 623752, 623776, 623778, 623784, 623786, 623787, 623788, 623799, 623800, 623801, 623802, 624004, 624005, 624006, 624008, 624011, 624012, 624016, 624017, 624018, 624019, 624024, 624028, 624030, 624041, 624042, 624046, 624054, 624055, 624056, 624057, 624064, 624066, 624070, 624071, 624073, 624076, 624077, 624080, 624082, 624089, 624099, 624100, 624101, 624104, 624107, 624109, 624110, 624112, 624114, 624117, 624119, 624121, 624151, 624158, 624162, 624167, 624170, 624618, 624622, 624643, 624678, 624679, 624682, 624683, 624720, 622539, 622540, 622570, 622572, 623734, 623748, 624739, and 624741.

Obstetrical and Gynecological Devices

2

No

US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI.

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

Serial Numbers: 2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049, 2025259,2802540,2700325

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and in Australia.

Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope