Recall Z-0339-2020— Western / Scott Fetzer Company
Class II · Terminated
Class II FDA medical device recall by Western / Scott Fetzer Company, initiated 2019-08-15, terminated 2020-11-18. It names one FDA 510(k) clearance: K142149. Product: Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.. Reason: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range.
- Recalling firm
- Western / Scott Fetzer Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-15
- Terminated
- 2020-11-18
- Firm location
- Westlake, OH, 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
Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
Reason for recall
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Data sourced from openFDA. This site is unofficial and independent of the FDA.