Portrait vital signs monitors recalled over batteries losing backup power
GE Healthcare is recalling 5,990 Portrait VSM patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
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: Scored 3 under the risk-of-harm criterion: loss of patient monitoring can delay recognition of a deteriorating patient, and no injuries are reported.
Plain-English summary
The Portrait VSM physiological patient monitor, model 6660000-666, is being recalled.
The firm describes a potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose the capability to hold charge and provide backup power. If this occurs, it will cause loss of patient monitoring and potentially delay recognising patient status changes requiring treatment.
The recall covers 5,990 units carrying UDI-DI 00195278561312, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
Sites operating an affected monitor should follow GE Healthcare's instructions.
The recalled product
- Product
- Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient monitor
- Affected units
- 5,990
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare Finland Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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