SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Waveleng
FDA device recall Z-0901-2015 · posted 2014-12-31 · Terminated
Recall details
- Recalling firm
- Nonin Medical, Inc
- Reason for recall
- Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.
- Action taken
- Consignees were sent a Nonin letter dated November 24, 2014. The letter described the problem and the product affected. They requested consignees to discontinue the use of the products and return it to Nonin. Consignees were asked to complete and return the "Medical Device Market Withdrawal Return Response Form". For questions and additional information they can contact James H. Russell at 763-577-2260 or e-mail jim.russell@nonin.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 5892 (5452 US, 440 OUS)
- Distribution
- To be provided later.
- Date initiated
- 2014-11-25
- Date posted
- 2014-12-31
- Date terminated
- 2015-09-01
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM (K132402) | Nonin Medical, Inc. | 2014-02-21 |