CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer
Western / Scott Fetzer is recalling Grab n Go Opti series VIPR system, distributed nationwide in the US. The recall was initiated on 15 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0340-2020
- FDA event ID
- 83857
- Recalling firm
- Western / Scott Fetzer, Westlake, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2019
- FDA classified
- 6 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 15 Aug 2019 | Recall initiated by company | |
| 6 Nov 2019 | Classified by FDA | +83 days |
| 13 Nov 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Product as listed by the FDA
Grab n Go Opti series VIPR system Model # PRX-9627 - 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.
Where it was distributed
Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.
Nationwide ArizonaCaliforniaConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMississippiNorth DakotaNew JerseyNevadaNew YorkOklahoma
Questions about this recall
Why was it recalled?
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Which lots are affected?
All Lot manufactured from 08/31/14 to 08/07/2019
Where was it sold?
Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 83857This product is part of a recall event; the main page for the event is Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer | Western / Scott Fetzer | Other | Nationwide | |
| CLASS II | Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer | Western / Scott Fetzer | Other | Nationwide | |
| CLASS II | Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer | Western / Scott Fetzer | Other | Nationwide | |
| CLASS II | Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer | Western / Scott Fetzer | Other | Nationwide |
More recalls from Western / Scott Fetzer
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Digital Vipr Roc-9839 Roberts Oxygen Ready to Use Digital recalled | Western/Scott Fetzer | Device Malfunction | Nationwide |
| Device | CLASS II | Roberts Digital VIPR System (with E-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR (head only) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR System (with E-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR System (with D-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |