Date Initiated by Firm | March 11, 2010 |
Create Date | December 14, 2016 |
Recall Status1 |
Terminated 3 on December 16, 2016 |
Recall Number | Z-0761-2017 |
Recall Event ID |
75743 |
510(K)Number | K082937 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical
personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX |
Code Information |
This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control. |
Recalling Firm/ Manufacturer |
Physio-Control, Inc. 11811 Willows Rd NE Redmond WA 98052-2003
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For Additional Information Contact | Rod J. Rylands 425-867-4261 |
Manufacturer Reason for Recall | Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010. |
FDA Determined Cause 2 | Environmental control |
Action | Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010. |
Quantity in Commerce | 1399 units (866 in the US and 533 outside US) |
Distribution | worldwide |
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 = MKJ
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