CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for
FDA device recall Z-1979-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Nihon Kohden America Inc
- Reason for recall
- Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
- Action taken
- Nihon Kohden sent an Urgent Medical Device Safety Notification and Field Correction letter dated June 3, 2014 to affected customers. Recall notification letter, dated June 3, 2014 was hand-delivered to site by Nihon personnel. The letter provided the following information: product description with codes and software version, reason for recall, field correction information and actions to be taken, MedWatch reporting information, and contact information for recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 430
- Distribution
- Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
- Date initiated
- 2014-06-03
- Date posted
- 2014-07-02
- Date terminated
- 2015-04-28
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 (K102376) | Nihon Kohden Corp. | 2010-12-07 |