Elite V series patient monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites potential cybersecurity issues raised in an FDA letter, with no stated defect consequence or reported harm.
Plain-English summary
The EDAN Patient Monitor models elite V5, elite V6 and elite V8 is being recalled by Edan Diagnostics. The record describes the product as follows: the V series Patient Monitor, including elite V5, elite V6 and elite V8, can perform long-time continuous monitoring of multiple physiological parameters.
The reason given in the enforcement record is that the firm received an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm's devices.
The record lists 342 units, with model, UDI-DI and serial or lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across a range of states listed in the record. The FDA has classified the action as Class II.
The record names no specific defect, consequence or reported harm. Facilities should follow Edan Diagnostics' instructions.
The recalled product
- Product
- Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Als
- Manufacturer
- Edan Diagnostics
- Affected units
- 342
Distribution
Part of a larger recall action
This product is one of 16 recalled by Edan Diagnostics 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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