GE Healthcare Portrait Core Services Software Recall Due to Software Vulnerability
GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0 (REF 5700592) patient monitoring systems due to a software vulnerability.
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 is classified as FDA Class II and involves a high-risk scenario where a vulnerability could lead to missed patient alarms, representing a risk of harm without reported injuries.
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling 11 units of GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592, which is a patient monitoring system.
A software vulnerability in the device may allow unauthorized persons to gain privileged access. This could result in the loss of patient monitoring, missed patient alarms, and/or unauthorized access to Protected Health Information (PHI).
The affected units are distributed worldwide, including nationwide in the state of Michigan, and in the Czech Republic, Finland, Germany, the Netherlands, Qatar, and the UAE. Affected serial numbers include SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
The recalled product
- Product
- GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Affected units
- 11
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 (12)
- GTIN 00198953056752
- Lot/Serial Numbers: SWT25510001TA
- 3M1D391215
- 3M1D411081
- 3M1D411083
- 3M1D3B100D
- SWT26110010TA
- SWT26070001TA
- SWT26120008TA
- 3M1D411080
- 3M1D411082
- 3M1D3B100C.
Distribution
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