Endoscopy video processors recalled over hot light guide and thermal injury risk
Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes a potential thermal injury to the patient and reports no injuries.
Plain-English summary
The Pentax Medical Video Processor, model number EPK-i8020c, UDI-DI 04961333247974, is being recalled. Affected units are identified by the serial numbers listed in the recall notice. The recall covers 144 units distributed in 20 states.
During endoscopic procedures using the EPK-i8020c video processor together with an i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke-like steam and noted that the light guide at the tip is hot during use and after the endoscope is removed from the patient, which may cause thermal injury to the patient's mucous membrane. The FDA classified the action as Class II.
Endoscopy units should check their serial numbers against the recall notice and follow the manufacturer's instructions for affected processors.
The recalled product
- Product
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Affected units
- 144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: EPK-i8020c
- UDI-DI: 04961333247974
- Serial Numbers: B0023Z1657
- D0023Z0245
- D0023Z0206
- D0023Z0125
- D0023Z0123
- D0023Z0119
- D0023Z0118
- D0023Z0117
- D0023Z0114
- D0023Z0112
- D0023Z0109
- D0023Z0108
- D0023Z0011
- C0023Z0087
- C0023Z0085
- C0023Z0074
- C0023Z0072
- C0023Z0021
Distribution
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