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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliSpace PACS 4.4

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 Class 2 Device Recall Philips IntelliSpace PACS 4.4see related information
Date Initiated by FirmApril 19, 2019
Create DateJune 10, 2020
Recall Status1 Completed
Recall NumberZ-2338-2020
Recall Event ID 85499
510(K)NumberK111804 
Product Classification System, image processing, radiological - Product Code LLZ
ProductIntelliSpace 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.
FEI Number 3002971142
Recalling Firm/
Manufacturer		 Philips Healthcare Informatics, Inc.
4430 Rosewood Drive Suite 200
Pleasanton CA 94588
For Additional Information Contact
877-328-2808
Manufacturer Reason
for Recall		Images may potentially become corrupt while using the system.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce26 units
DistributionWorldwide 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 CycleTPLC 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.
510(K) Database510(K)s with Product Code = LLZ
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