iM20 patient monitors recalled over potential cybersecurity issues flagged by FDA
Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor 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 iM20 Patient Monitor is being recalled by Edan Diagnostics. The record describes the product as follows: the iM20 Patient Monitor System can perform long-time continuous monitoring of multiple physiological parameters, including ECG.
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 377 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
- Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that th
- Manufacturer
- Community Products, LLC
- Affected units
- 1,096
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 (20)
- Model/Catalog Number: K320. ID Codes: K32020130515AA
- K32020130603AA
- K32020130606AA
- K32020130607AB
- K32020130610AA
- K32020130612AA
- K32020130617AA
- K32020130617AB
- K32020130618AA
- K32020130709AA
- K32020130713AA
- K32020130713AB
- K32020130717AB
- K32020130802AA
- K32020130805AA
- K32020130807AA
- K32020130808AA
- K32020130808AB
- K32020130812AA
- K32020130812AB
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Community Products, LLC 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.
See all 3 products in this recall →Related recalls
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