| | Class 2 Device Recall Nihon Kohden NKV550 Ventilator System |  |
| Date Initiated by Firm | July 20, 2021 |
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| Create Date | September 08, 2021 |
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| Recall Status1 |
Terminated 3 on April 21, 2023 |
| Recall Number | Z-2435-2021 |
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| Recall Event ID |
88411 |
| 510(K)Number | K181695 K192307 |
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| Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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| Product | 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. |
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| Code Information |
All serial numbers between NKV5502019xxxx - NKV5502112xxxx and the following serial numbers below:
NKV55019270055,
NKV55019370098R,
NKV55019430125R,
NKV55019470156R,
NKV55019470160,
NKV55020130200,
NKV55020140213R,
NKV55020140226R,
NKV55020140229,
NKV55020150241,
NKV55020150252,
NKV55020160268,
NKV55020160276,
NKV55020160277,
NKV55020160292R,
NKV55020160296,
NKV55020160297,
NKV55020160304,
NKV55020160307,
NKV55020160308,
NKV55020160310,
NKV55020160312,
NKV55020170317,
NKV55020170318,
NKV55020170325,
NKV55020170335,
NKV55020170336,
NKV55020170341,
NKV55020170342,
NKV55020170343,
NKV55020170346,
NKV55020170347,
NKV55020170349,
NKV55020170350,
NKV55020170352,
NKV55020170354,
NKV55020170357,
NKV55020170360,
NKV55020180365,
NKV55020180366,
NKV55020180369,
NKV55020180370,
NKV55020180371,
NKV55020180372,
NKV55020180373,
NKV55020180374,
NKV55020180375,
NKV55020180376,
NKV55020180378,
NKV55020180379,
NKV55020180381,
NKV55020180383,
NKV55020180384,
NKV55020180385,
NKV55020180387,
NKV55020180391,
NKV55020180392,
NKV55020180396,
NKV55020180397,
NKV55020180398,
NKV55020180399,
NKV55020180400,
NKV55020180401,
NKV55020180402,
NKV55020180403,
NKV55020180405,
NKV55020180406,
NKV55020180408,
NKV55020180409,
NKV55020180410,
NKV55020180411,
NKV55020180412,
NKV55020180413 |
Recalling Firm/
Manufacturer |
NIHON KOHDEN ORANGEMED, INC
1800 E Wilshire Ave
Santa Ana CA 92705-4617
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| For Additional Information Contact | Nihon Customer Service
949-502-6448 Ext. 7101 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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 FSN@orange-med.com 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 FCN@orange-med.com.
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
|
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| Quantity in Commerce | 1,999 units |
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| Distribution | 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = CBK
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