Philips eCareManager versions recalled due to unapproved Sentry Score software
Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.
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: This is an FDA Class II medical device recall involving unapproved software deployed in a clinical decision-support context. Although no injuries or illnesses have been reported, the use of unauthorized software in healthcare delivery presents a risk of harm and meets the criteria for a High severity rating.
Plain-English summary
Philips North America LLC is recalling eCareManager versions 4.2.1, 4.3.2, 4.3.3, 4.5.1, 4.5.2, and 4.6.0. This software tool is intended for use by trained medical staff to provide supplemental remote support to bedside care teams in the management of hospitalized patients.
The recall is due to the Sentry Score software feature within eCareManager having been deployed and distributed without prior FDA approval.
The affected software versions have been distributed worldwide, including throughout the United States and to Australia. Approximately 36 units are affected.
Healthcare facilities and providers using the affected eCareManager versions should contact Philips North America LLC for information regarding this recall and for guidance on managing their use of the product.
The recalled product
- Product
- eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside…
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 36
Distribution
Distributed nationwide across the United States.
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