ECG trunk cables recalled because improper module placement can cause overheating
GE is recalling 29,225 MAC VU360 acquisition trunk cables and module holders because incorrect placement of the module can wear the cable until it overheats in use.
What this means for you
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: a worn cable that can overheat in patient use is a burn and electrical hazard, and no injuries are reported.
Plain-English summary
The MAC VU360 Acquisition Trunk Cable and Module Holder, used with a high performance multichannel resting electrocardiograph, model number 2030360-001, product codes VU2 and VU4, is being recalled.
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable, visible as a damaged sheath or exposed wires. If a damaged cable is not recognized and removed from service, it can overheat with continued use.
The recall covers 29,225 units carrying UDI-DI 00840682125499. Distribution was worldwide, including nationwide in the United States and to Australia, Austria and Bahrain among other countries. The FDA has classified the action as Class II.
The enforcement record describes the overheating pathway and reports no injuries. Sites should inspect cables for a damaged sheath or exposed wires and follow GE's instructions.
The recalled product
- Product
- MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — ECG accessory
- Affected units
- 29,225
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 (1)
- UDI-DI: 00840682125499
Distribution
Distributed nationwide across the United States.
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