The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2338-2020·Announced 2020-06-17

Philips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption

Philips Healthcare Informatics is recalling 26 units of IntelliSpace PACS 4.4 because images may potentially become corrupt while using the system.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for image corruption, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips Healthcare Informatics, Inc. is recalling 26 units of IntelliSpace PACS 4.4, product number 837507. The recall is being conducted because images may potentially become corrupt while using the system.

The affected product is intended to be used by trained professionals, including but not limited to physicians, nurses, and medical technicians. The recall covers specific product versions, including 4.4.233.8, 4.4.516.0, 4.4.516.21, 4.4.532.1, 4.4.532.11, 4.4.541.0, 4.4.541.2, 4.4.542.0, 4.4.543.0, 4.4.543.1, 4.4.551.73, 4.4.552.14, and 4.4.552.18.

The product was distributed worldwide, including nationwide in the United States and in Canada, Brazil, Ireland, New Zealand, the United Arab Emirates, and the United Kingdom. There was government distribution but no military distribution. The source text does not specify instructions for consumers or affected users.

The recalled product

Product
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.
Manufacturer
Philips Healthcare Informatics, Inc.
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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