| Date Initiated by Firm | June 18, 2020 |
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| Create Date | August 14, 2020 |
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| Recall Status1 |
Terminated 3 on January 10, 2023 |
| Recall Number | Z-2811-2020 |
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| Recall Event ID |
86025 |
| 510(K)Number | K090785 K131382 |
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| Product Classification |
Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
|
| Product | Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. |
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| Code Information |
Product #: 989803191021 Manufacturing date codes: prior to 2020-03 |
Recalling Firm/
Manufacturer |
Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
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Manufacturer Reason
for Recall | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | Philips Healthcare sent a customer notification letter dated June 2020 explaining the potential issues observed with their products. This letter instructs the consumer to contact the company with any reports of issues associated with this failure. |
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| Quantity in Commerce | 118 units |
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| Distribution | World wide distribution.
Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed. |
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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 = MWI
510(K)s with Product Code = MWI
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