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Class 2 Device Recall Philips IntelliSpace PACS 4.4 |
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Date Initiated by Firm |
April 19, 2019 |
Create Date |
June 10, 2020 |
Recall Status1 |
Completed |
Recall Number |
Z-2338-2020 |
Recall Event ID |
85499 |
510(K)Number |
K111804
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Product Classification |
System, image processing, radiological - Product Code LLZ
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Product |
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. |
Code Information |
Product versions: 4.4.233.8 UDI N/A, 4.4.516.0 UDI N/A, 4.4.516.21 UDI N/A, 4.4.532.1 UDI N/A, 4.4.532.11 UDI N/A, 4.4.541.0 UDI N/A, 4.4.541.2 UDI (01)00884838074781(11)160825(10)4.4.541.2, 4.4.542.0 UDI (01)00884838074781(11)160822(10)4.4.542.0, 4.4.543.0 UDI (01)00884838074781(11)170131(10)4.4.543.0, 4.4.543.1 UDI (01)00884838074781(11)170321(10)4.4.543.1, 4.4.551.73 UDI (01)00884838074781(11)180907(10)4.4.551.73, 4.4.552.14 UDI (01)00884838074781(11)180509(10)4.4.552.14, and 4.4.552.18 UDI (01)00884838074781(11)181108(10)4.4.552.18. |
Recalling Firm/ Manufacturer |
Philips Healthcare Informatics, Inc. 4430 Rosewood Drive Suite 200 Pleasanton CA 94588
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For Additional Information Contact |
877-328-2808
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Manufacturer Reason for Recall |
Images may potentially become corrupt while using the system.
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FDA Determined Cause 2 |
Device Design |
Action |
The recalling firm issued a customer information letter beginning April 29, 2019, via FedEx (for the U.S. and Canadian customers) informing the consignee of the issue, their site was affected, and a time needed to be scheduled for an onsite visit. |
Quantity in Commerce |
26 units |
Distribution |
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, LA, MA, MI, MO, NC, NH, NY, OR, and TX. There was government distribution but no military distribution. The countries of Canada, Brazil, Ireland, New Zealand, United Arab Emirates, and the United Kingdom. |
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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = PHILIPS HEALTHCARE INFORMATICS, INC.
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