FDAFDA · Food and drugs·Recall number Z-0403-2016
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.
Published December 16, 2015 · Recall initiated: November 17, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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