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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68444

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

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Event summary

Timeline bucket
June 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nellcor Puritan Bennett Inc. (dba Covidien LP)

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

Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.

Z-1844-2014
Recall number
Z-1844-2014
Initiated
June 03, 2014
Classification
Class II
Status
Terminated
Quantity
104

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.

Code information

serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, Germany, Guatemala, Israel, Japan, Kazakhstan, Kenya, Lebanon, Libya, Macedonia, Mexico, Montenegro, Morocco, Panama, Peru, Russia, Saudi Arabia, Singapore, Switzerland, Taiwan, Tunisia, Turkey, Yugoslavia (Serbia & Montenegro) Including GOVT/VA/Military