FDA Device recall Z-1733-2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module by Terumo Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1733-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. 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
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
Identifiers
| code_info | Catalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2…Catalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356,2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1733-2013%22
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