Medrad Recalls DC Power Cables for Veris MR Vital Signs Monitor
Medrad Inc is recalling 1,066 DC power cables for the Veris MR Vital Signs Monitor due to a design issue that could cause shorting and heating.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). The potential for heating and melting of the cable jacket represents a significant hazard.
Plain-English summary
Medrad Inc is recalling 1,066 DC power cables (part number 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor. The recall covers cables with catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, and 3014268W.
The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting, which can result in heating or melting of the cable jacket. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries. The source text does not specify instructions for consumers or healthcare facilities regarding the next steps for this recall.
The recalled product
- Product
- DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
- Manufacturer
- Medrad Inc
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,066
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 (9)
- Catalog numbers 3011992
- 3011992W
- 3011993
- 3011993W
- 3011994
- 3011994W
- 3011996
- 3011996W
- 3014268 and 3014268W.
Distribution
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