Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) commun
FDA device recall Z-1768-2017 · posted 2017-03-20 · Terminated
Recall details
- Recalling firm
- Nihon Kohden America Inc
- Reason for recall
- The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
- Action taken
- A technical bulletin was issued on March 7, 2017 to make Life Scope G9 users aware of following interaction: the CNS 6201A and CNS 9701A (using the noted software versions) will not Auto Resume when a patient is reconnected to a Life Scope G9 if the patient tile is Paused. Therefore, each time a patient is reconnected to the Life Scope G9, the Pause must be cancelled and monitoring manually resumed on the CNS 6201A or CNS 9701A. A customer letter dated March 13, 2017 was sent to all customers to inform them that Nihon Kohden America (NKA) is voluntarily notifying them that the Pause function on central monitors (models CNS 6201A and CNS 9701A; Software Versions 01-06, 02-10 and 02-40), will not automatically resume when connected to a Life Scope G9 patient monitor (model CSM 1901; versions 01-19, 01-20 and 01-21). Customers are informed of issue,risk to health, and instructions. Customers are instructed to complete the attached reply form and return it to the fax number or email address on the form. Customers with questions are instructed to contact NKA Technical Services Group at (800) 325-0283, Option 6 (M-F, 8am-5pm PDT) or by email at G9@nkusa.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 654 units total (230 units in US)
- Distribution
- Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Afr
- Date initiated
- 2017-03-13
- Date posted
- 2017-03-20
- Date terminated
- 2017-10-01
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Nihon Kohden CSM 1901 Bedside Monitor (K151080) | Nihon Kohden | 2015-11-05 |