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Recall Observatory FDA recall evidence

Device product

INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.

Z-0760-2017

July 21, 2016

Class II

Product summary

Firm
Inovo, Inc
Event
Event 75312
Status
Terminated
Classification
Class II
Quantity
117 units
Official record key
device-enforcement:Z-0760-2017

Official wording

Reason: Device can fail during operation.

Code information: Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.

Distribution pattern: US Nationwide Distribution to states of: AL, AR, CT, FL, IA, KS, KY, MD, MI, MN, MO, NE, NJ, NV, NY, OH, RI, SC, TN, TX, UT, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device can fail during operation.