| Date Initiated by Firm | February 28, 2024 |
|---|
| Date Posted | March 27, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1387-2024 |
|---|
| Recall Event ID |
94185 |
| 510(K)Number | K161164 |
|---|
| Product Classification |
System, network and communication, physiological monitors - Product Code MSX
|
| Product | CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X |
|---|
| Code Information |
UDI-DI: (01)00884838099128(10)C.03.00;
Serial Numbers: 5T6W-21KC-4
3L0R-7AHH-C
1F1G-01JC-6
415A-26K6-9
605K-5AGH-2
5J5G-0ZNF-4
7A6D-4TL3-Y
233Z-0LJ3-C
142W-3VM1-3
1863-19MD-E
3F0T-7AHH-C
4R5K-5AGH-W
2T5M-55J9-W
0U6Z-70HU-B
795Z-7FHX-E
2K3W-3PJ8-0
3T5Z-7FHX-2
0B13-0MNA-8
0R0E-63JK-C
644J-1CJJ-1
470D-63JK-A
2022-0XNW-V
5W2A-5MGJ-D
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6944-5RM5-A
7G7Y-76MW-C
0L09-3WPK-J
2R1E-50P2-3
3967-33KR-R
3H3M-28MC-X
4E1V-5LH0-8
5Y57-68PX-9
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3W5D-7UMF-J
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181U-7TJA-2
2V6Z-1ZL8-C
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591H-1KG1-9
194W-72P0-E
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2044-77KZ-8
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0U41-6BK3-L
6G5N-4LGG-3
232E-2FMY-X
6R22-07LZ-R
1P5K-5AGH-2
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0550-53NK-T
0F13-59N8-K
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4673-5WKF-5
1F6P-0PLF-T
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023M-4WMG-F
490H-6AMX-8
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3L1J-1KG1-V
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5C7L-0VKT-5
5M4Z-6KKD-J
5Z4R-2LKY-7
6A6D-4TL3-Z
6T18-4CLX-9
6V5D-7UMF-J
735A-26K6-0
7N7D-62PF-7
7V0B-3WPK-R
7W5X-2VNH-M
2U0H-23HD-A
136H-7PGV-U
6F1L-1TLH-P
574R-37N1-B
1X0H-23HD-2
604G-1GL2-M
7F2Y-65P4-A
1H3G-41PZ-Y
|
Recalling Firm/
Manufacturer |
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
|
Manufacturer Reason
for Recall | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | An URGENT Medical Device Correction dated 2/27/24 was sent to customers.
Actions that should be taken by the customer / user in order to prevent risks for patients or users:
1. The Care Assist mobile application should be used in conjunction with other monitoring devices such as a bedside monitor, telemetry monitor and central monitor which continue to provide visual and audible alarm information to inform clinicians of changes in patient status.
2. Customers should update their iOS devices to version 4.1.2 of Care Assist mobile application or greater to eliminate the software defect affecting the annunciation of custom ringtones.
3. Customers should complete the Urgent Medical Device Correction Response Form at the end of the notification to submit both their acknowledgement of this recall and confirm understanding of actions to be taken.
4. This communication should be shared with all clinical staff to review and understand.
5. Place this Urgent Medical Device Correction notification with the documentation of the Care Event and Patient Information Center iX (PlC ix) Revision 4.
For Distributors:
Philips is requesting customers to return a Response Form to acknowledge receipt and understanding of the Medical Device Correction and confirm that the information from this Letter has been properly distributed to all users that handle the affected product.
Together with this letter we are providing a list of affected products that Philips has sold to your organization. As distributor of the affected products, we kindly request that you:
Send the attached Medical Device Correction to each customer to whom you have distributed any affected product as soon as possible and no later than? days, together with the Reply Card.
Perform a good faith effort to ensure Notification and Reply Form arc deliver to the customer with a minimum of three attempts, and if possible, using multiple contact methods.
Actions planned by Philips to correct the problem
1, The action by Philips |
|---|
| Quantity in Commerce | 2,323 Units |
|---|
| Distribution | Worldwide - US Nationwide distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = MSX
|
|---|
