Aizu Olympus Co., Ltd. recalls
4 recalls on record · FDA
Every recall we have on record for Aizu Olympus Co., Ltd., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract…
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Tracheal fiberscope-airway management, which includes observation to access airway…
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
EVIS EXERA III Bronchovideoscope
The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.