Recall Z-2338-2020 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
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.
| Date | Apr 19, 2019 |
| Status | Completed |
| Reason | Images may potentially become corrupt while using the system. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111804 | INTELLISPACE PACS 4.X Philips Healthcare Informatics, Inc., Jul 28, 2011 |