Reported Jun 17, 2020 · Completed
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including…
Philips Healthcare Informatics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare Informatics, Inc. · 4430 Rosewood Drive Suite 200 · Pleasanton, CA · 94588
Is this the product you have?
- IntelliSpace PACS 4.4
- Product number 837507 - Product Usageintended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians
- Lot codes and dates
- Product versions4.4.233.8 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
- Amount recalled
- 26 units
Where it was sold
Why it was recalled
Images may potentially become corrupt while using the system.
This product could cause temporary or reversible health problems — stop using it.
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