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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69441

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 23, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Invacare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.

Z-0577-2015
Recall number
Z-0577-2015
Initiated
September 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Invacare Corporation
Quantity
5,963

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.

Code information

The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099. The serial number range is as follows for the finished device: 14GF053772-14HF032124 (Sequential serial numbers)

Distribution pattern

Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.