Compass Health recalls REX Pressure Therapy System user manuals due to an error indicating DVT prevention without proper FDA approval. This may lead to unsafe use of the device for deep vein thrombosis prevention.
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
Compass Health is recalling the REX Pressure Therapy System user manuals because they contain an error suggesting the device can prevent deep vein thrombosis (DVT) without the necessary FDA approval. This could lead to unsafe use of the device for DVT prevention.
The user manual incorrectly states the device can prevent deep vein thrombosis (DVT) without having received FDA approval for this use. This error could lead to unsafe use of the device for D:VT prevention if users follow the manual's incorrect guidance.
Users of the REX Pressure Therapy System who have the DVTREX-U or DVTREX-L models are affected. Those with medical conditions requiring DVT prevention are at higher risk.
Check for the DVTREX-U or DVTREX-L models with serial numbers starting with 00092237622926 or 00092237622933. All units produced are affected.
Check if the manual contains the error about DVT prevention without FDA approval.
The user manual contains an error indicating the device may be used for deep vein thrombosis prevention without FDA approval.
DVTREX-U and DVTREX-L models with serial numbers starting with 00092237622926 or 00092237622933.
The recall record does not specify a remedy.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1398-2023 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1398-2023 from Compass Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
