Lessons from a Recent Recall
A recent Class I recall (not pictured) of a medical monitor with a hospital network connected central station stimulates some generalities about software, “fixes”, and connectivity. (Class I recalls are defined by the FDA as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.)
The use of the product in question was given as:
- a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs
Curiously only one customer was identified as having received the product, or at least this particular version of the product. While the manufacturer and product in question is a matter of public record, and available at the link, I chose not to include it here because my objective is not to repeat the recall information, but to suggest the reasons for the recall, an associated labeling issue, and offer some general lessons.
