Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 24, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corporation recalled CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hemat… - a moderate-severity action.
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hemat… was recalled by Terumo Cardiovascular Systems Corporation in July 24, 2013. Reason: Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains in…. Check the official notice for the remedy. Verify recall #Z-1731-2013 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains in….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- July 24, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1731-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1731-2013) was formally reported on July 24, 2013, with the manufacturer initiating the action on February 27, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records list the affected scope as 3972 unit since 4/26/12.
The documented reason for this recall is: Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issu… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3972 unit since 4/26/12
Related Recalls
6
3 from same agency
Product description
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Reason for recall
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1731-2013 |
| Date reported | July 24, 2013 |
| Date initiated | February 27, 2013 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Ann Arbor, MI |
| Affected scope | 3972 unit since 4/26/12 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1731-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 3972 unit since 4/26/12.
Why was this product recalled? ▼
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2013. Severity: Moderate. Recall number: Z-1731-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, 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, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1731-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 24, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.