| Date Initiated by Firm | January 18, 2023 |
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| Date Posted | October 01, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0007-2025 |
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| Recall Event ID |
95301 |
| 510(K)Number | K151681 |
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| Product Classification |
Detector and alarm, arrhythmia - Product Code DSI
|
| Product | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 |
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| Code Information |
UDI-DI: 00884838051492;
Serial Numbers: DE43800129 through DE43812627 |
| FEI Number |
3006648320
|
Recalling Firm/
Manufacturer |
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
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Manufacturer Reason
for Recall | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | An IMPORTANT PRODUCT NOTICE dated 1/18/23 was sent to customers.
The actions planned by Philips to correct the problem
A Philips representative will reach out to you to arrange a replacement of the sample gas pump.
Affected products and how to identify them
Affected product is the 866173 lntelliVue G7m Anesthesia Gas Module. Both the product number and the serial number on the G7m product is contained on the back of the product, preceded by "REF" and "SN", respectively.
If you need any further information or support concerning this issue, please contact your local Philips representative. |
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| Quantity in Commerce | 8,449 devices |
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| Distribution | US Nationwide. Global Distribution. |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DSI
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