CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressur
FDA device recall Z-2742-2015 · posted 2015-09-09 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
- Action taken
- A voluntary Urgent Medical Device Correction notice that clearly explains initial in-vivo calibration requirements, device operating ranges, and temperature measurements was sent on 08/17/2015, via express mail to consignees of CDI System 500 v1.69. Following the initial notice, Terumo will be updating the Operators Manual and will send the new manual to each consignee when available. One manual per unit at each facility will be provided. Customers with questions and return response forms may contact: Terumo Recall Email: tcvs.recall@terumomedical.com Terumo Recall Fax: 734-741-6149 Terumo CVS Customer Service: 1.800.521.2818, Monday - Friday, 8 a.m. 6 p.m. ET.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DRY
- Quantity affected
- 4638
- Distribution
- 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,
- Date initiated
- 2015-08-07
- Date posted
- 2015-09-09
- Date terminated
- 2016-05-31
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K133658) | Terumo Cardiovascular Systems Corp. | 2014-07-25 |