CASE cardiac testing systems may spark at the printer head
CASE v7.0 Cardiac Testing Systems are being recalled because electrical sparking may occur at the printer head, and ignition of thermal paper could cause serious thermal injury.
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: FDA Class II recall where sparking could ignite printer paper and cause thermal injury, a risk of harm with no injuries reported in the source.
Plain-English summary
The CASE v7.0 Cardiac Testing System, model number 3031234-001, UDI-DI 00195278617644, is being recalled. The action covers 1,835 units.
Electrical sparking may occur at the printer head. According to the manufacturer, if the electrostatic discharge printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper, and ignition of the paper could potentially result in serious thermal injury. The FDA classified the action as Class II.
Distribution was worldwide, covering the United States nationwide and Algeria, Australia and other markets. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the model number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Affected units
- 1,835
Distribution
Distributed nationwide across the United States.
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