Recall Z-1586-2013— Medrad Inc
Class II · Terminated
Class II FDA medical device recall by Medrad Inc, initiated 2013-04-15, terminated 2014-04-03. It names one FDA 510(k) clearance: K042569. Product: DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient. Reason: The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket..
- Recalling firm
- Medrad Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-15
- Terminated
- 2014-04-03
- Firm location
- Indianola, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Reason for recall
The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.
Data sourced from openFDA. This site is unofficial and independent of the FDA.