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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70684

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

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Event summary

Timeline bucket
March 02, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Cardiovascular Us Sales, Llc

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.

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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

The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.

Z-2083-2015
Recall number
Z-2083-2015
Initiated
March 02, 2015
Classification
Class II
Status
Terminated
Quantity
104 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.

Code information

Device Part number: 66 79 847 Serial Numbers: 4, 14-24, 26-29, 31, 37, 40, 56, 138, 199, 205, 367, 369-372, 391, 394-395, 416, 466-491, 517, 519, 525, 567-568, 570, 582-583, 606, 613, 619, 627, 629-631, 633, 635-641, and 643-665

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand and United Arab Emirates.

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