REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
Reported: April 26, 2023 Initiated: March 7, 2023 #Z-1398-2023
Product Description
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
Reason for Recall
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
Details
- Recalling Firm
- Compass Health Brands (Corporate Office)
- Units Affected
- 30 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Middleburg Heights, OH
Frequently Asked Questions
What product was recalled? ▼
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L. Recalled by Compass Health Brands (Corporate Office). Units affected: 30 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1398-2023.
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