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 me

Is my product affected?

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.

• UPC 00884838074781

Check against the official notice below — it lists the full affected range.

What happened

Philips Healthcare Informatics, Inc. is recalling IntelliSpace PACS version 4.4 (product number 837507), a medical imaging system intended for use by trained healthcare professionals such as physicians and nurses. The recall affects 26 units distributed worldwide, including locations across the United States, Canada, Brazil, Ireland, New Zealand, the United Arab Emirates, and the United Kingdom. The system is being recalled because images may potentially become corrupt while using the system. The affected product versions range from 4.4.233.8 through 4.4.552.18.

The recall notice does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Images may potentially become corrupt while using the system.

Details from the source

Reason for recall: Images may potentially become corrupt while using the system. 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. Quantity: 26 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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