| Class 2 Device Recall Philips |  |
Date Initiated by Firm | April 29, 2014 |
Date Posted | June 13, 2014 |
Recall Status1 |
Terminated 3 on April 06, 2015 |
Recall Number | Z-1789-2014 |
Recall Event ID |
68226 |
510(K)Number | K061256 |
Product Classification |
Monitor, apnea, home use - Product Code NPF
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Product | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. |
Code Information |
989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384 |
Recalling Firm/ Manufacturer |
Childrens Medical Ventures 191 Wyngate Dr Monroeville PA 15146-3045
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For Additional Information Contact | Customer Support 412-380-8881 |
Manufacturer Reason for Recall | The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed. |
FDA Determined Cause 2 | Component design/selection |
Action | Philips sent an Urgent Medical Device Correction letter dated April 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This Customer Information is intended to inform you about:
1.what the problem is and under what circumstances it can occur
2.the actions that you as a customer can take to minimize the effect of the problem
3.the actions planned by Philips to correct the problem.
If you need any further information or support concerning this issue, please contact your local Philips representative: For further questions please call (412) 380-8881.
Philips apologizes for any inconveniences caused by this problem. |
Quantity in Commerce | 112 |
Distribution | Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada. |
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 = NPF
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