Pentax Medical Recalls Video Systems Due to Missing Isolation Transformers
Pentax Medical is recalling 241 units of 7245C, 7245C/E, and 7245D Computer Digital Video Systems because they may have been shipped without required 9175 isolation transformers.
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: The recall involves a medical device where a required safety component (isolation transformer) is missing. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Pentax of America Inc is recalling 241 units of the 7245C, 7245C/E, and 7245D Computer Digital Video Systems. These devices are used to electronically record, display, transfer, and store digital video data of swallowing behavior in the pharyngeal area for medical and pedagogical applications. The recall covers units distributed worldwide and across the United States.
The recall was initiated because Pentax Medical did not always provide the required 9175 isolation transformers with these systems. The 9175 isolation transformers are used with the 7245C, 7245C/E, and 7245D, as well as 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems. The source text does not specify the exact nature of the hazard associated with the missing transformers, nor does it report any injuries or illnesses.
Healthcare facilities and users should check their inventory for the affected serial numbers listed in the recall notice. If a unit is found, it should be removed from service and the manufacturer contacted for further instructions.
The recalled product
- Product
- 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical application
- Manufacturer
- Pentax of America Inc
- Hazard
- Affected units
- 241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Pentax of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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