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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71937

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

Open FDA event record

Event summary

Timeline bucket
August 07, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems 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

CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.

Z-2742-2015
Recall number
Z-2742-2015
Initiated
August 07, 2015
Classification
Class II
Status
Terminated
Quantity
4638

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

Code information

500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500; software version 1.69.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, Canada, Chile, Colombia, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates.