Full electric lightweight homecare beds recalled over pendants that may overheat
Medline is recalling 35,694 units of the Full Electric Lightweight Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.
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: Potential cybersecurity issues. The notice does not report any illnesses, injuries or deaths. The notice states: "potential cybersecurity issues with various of the firm device"
Plain-English summary
Medline beds labeled as Full Electric Lightweight Homecare Bed, REF MDR107003L are being recalled by Medline Industries, LP.
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. The firm states that in rare and atypical scenarios, such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components or motor, the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline states it has received a total of 58 complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
The record lists 35,694 units under UDI/DI 40080196294344, all lots. Distribution covered the US, California, Pennsylvania, Guam and the US Virgin Islands as listed in the record. The FDA has classified the action as Class I, its most serious category.
Users and caregivers should follow Medline's instructions, including any guidance on operating within the bed's specified weight limit and on inspecting the pendant and its cord.
The recalled product
- Product
- Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP)…
- Manufacturer
- Edan Diagnostics
- Category
- Medical Device — Homecare bed
- Affected units
- 377
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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