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.
FDA Recall Z-2338-2020 · Posted None
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Recalling FirmPhilips Healthcare Informatics, Inc.
Recall StatusCompleted
Product CodeLLZ
Date Initiated2019-04-19
Product Quantity26 units
Reason for Recall
Images may potentially become corrupt while using the system.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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