Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is in
FDA device recall Z-1543-2015 · posted 2015-04-29 · Terminated
Recall details
- Recalling firm
- Nihon Kohden America Inc
- Reason for recall
- Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
- Action taken
- The firm, Nihon Kohden, sent an Urgent Medical Device Alert" letter dated 4/14 /15 to customers. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using the RNS for primary alarm notification and instead utilize the CNS and or the Bedside monitor for primary alarm notification, until such time NKA can provide corrective measures to your facility; Inform potential users in your organization of this notification, and complete the attached reply form and return it by fax (949) 580-1550 or email it to RNS_Replay@nkusa.com. Customers with questions are instructed to contact NKA Technical Support Center at (800) 325-0283 Ext 6 (available 24 hours a day/7 days/week).
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 208 units
- Distribution
- US Distribution to states of: AL, CO, DE, FL, GA, HI, KY, IL, IN, MA, MD, MI, MN, MO, NC,, ND, NJ, NY.OH, PA, and WV.
- Date initiated
- 2015-04-14
- Date posted
- 2015-04-29
- Date terminated
- 2015-10-01
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES (K023475) | Nihon Kohden America, Inc. | 2002-10-24 |