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Class 2 Device Recall Philips |
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Date Initiated by Firm |
June 08, 2021 |
Create Date |
August 18, 2021 |
Recall Status1 |
Terminated 3 on August 10, 2023 |
Recall Number |
Z-2315-2021 |
Recall Event ID |
88336 |
510(K)Number |
K160743
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system |
Code Information |
Model: 728321
S/N UDI:
40012 (01)00884838059498(21)40012
Model: 728332
40004 (01)00884838059504(21)40004
Software Version: 4.1.10 SynchRight Option
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Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
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Manufacturer Reason for Recall |
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
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FDA Determined Cause 2 |
Software design |
Action |
Philips issued Urgent Medical Device Correction letter dated 6/8/21 to consignees via certified mail. Letter states reason for recall, health risk and action to take:
following steps:
Go to Preferences> Regional Settings > Weight units, select the Weight units to Kg.
Step 1: Verify that the patient weight unit is set to Kg, rather than Lbs.
Step 2: Change the weight unit to Kg if weight unit is set to Lbs, referring to the screenshot below
Step 3: Log out and then log back in to make the changes effective.
Please share this notice with all those who need to be aware within your organization.
Please complete and return the attached response form to Philips Healthcare promptly upon receipt and no later than 30 days from receipt, via email to CTNM.QARA@PHILIPS.COM
The software update is planned to be released in the 3rd quarter of 2021. Once the software update is released, a Philips representative will contact you to schedule a software update to permanently resolve the issue.
For North America, contact the Customer Care Solutions Center (1-800-722-9377). |
Quantity in Commerce |
2 units |
Distribution |
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA. |
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 = JAK and Original Applicant = Philips Medical Systems (Cleveland), Inc.
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