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Terminated

Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.

FDA Recall Z-2435-2021 · Posted None

Recalling FirmNIHON KOHDEN ORANGEMED, INC
Recall StatusTerminated
Product CodeCBK
Date Initiated2021-07-20
Date Terminated2023-04-21
Product Quantity1,999 units

Reason for Recall

Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.

Firm Action

The firm Nihon Kohden OrangeMed, Inc., sent an "URGENT-Medical Device Correction Recall Safety Notice" letter to its customers on July 26, 2021. The letter describes the product, issues and actions to be taken. The customers were instructed to do the following prior to actions being implemented by the manufacturer: 1. Pass this notice on to all those who need to be aware within your organization and to any organization where the affected devices have been transferred. 2. Perform Device Check and Circuit Check as instructed in the NKV-550 ventilator Operator s Manual. A defective regulator can be identified during the Device Check and Circuit Check. 3. If the gas outlet from the hospital wall has an individually adjustable pressure regulator, adjust the outlet pressure to 16 psi for the air and O2 gases at the NKV-550 ventilator. This will allow the ventilator not to depend on its internal regulators to regulate the gas pressure. 4. If the ventilator has a failed internal regulator, remove the ventilator from service and contact the manufacturer or your local representative of the manufacturer. 5. Please complete the attached acknowledgement form and return to [email protected] within 5 days of receipt. Please review and distribute the information with your staff members who need to be aware of the contents of this communication. Please retain a copy of this notice and include it with the Operator s Manual of this device. For further information, please contact your local representative of the manufacturer or email the manufacturer at [email protected]. Telephone (Monday through Friday, 8:00 am to 5:00 pm, Pacific Time) Main Office: +1 (949) 502-6448 Customer Service: Ext: 7101 Technical Support: Ext. 7102 Clinical Support: Ext. 7103

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: AZ, CA, NY, MA, VT, LA, DC, PA, FL, UT and OUS (countries) of: Brazil, Japan, Ireland, Poland, Scotland, Germany, Kazakhstan, Spain, Slovenia, Germany/Bulgaria, Russia, India, Palestine, Libya, Jordan Kuwait, Lebanon, Syria, Turkey, South Africa, United Arab Emirates, Mexico, Colombia, Peru, Costa Rica, Barbados, Ecuador, Bahamas, Bolivia, St Kitts & Nevis, St. Martin, Chile, Thailand, Laos, Philippines, Malaysia, Nepal and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192307Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2020-01-10K181695Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2018-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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