Compass Health recalls MediPress pneumatic compression system model 6104M-S due to missing premarket clearance. All units are affected; no remedy stated in official notice.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Compass Health is recalling all MediPress Full Arm (Medium)-Segmental Gradient compression systems (model 610:4M-S) because they were designed without proper premarket clearance. This means the device may not be safe for medical use as it lacks required regulatory approval.
The device was designed without proper premarket clearance, meaning it hasn't been approved by the FDA for medical use. This could lead to potential safety issues if the device is used without regulatory approval.
Medical facilities using the MediPress Full Arm compression system are affected. Patients receiving this device could be at risk if it's not properly cleared by regulators.
Check for the model number 6104M-S on the device. All units with this model are affected, regardless of serial number or lot.
Look for the model number 6104M-S on the device to confirm it is affected.
The official recall notice does not state any remedy or fix for this device.
Check for the model number 6104M-S on the device. All units with this model are affected.
The device was not approved by the FDA for medical use due to missing premarket clearance, so it is not safe for medical use.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1345-2019 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1345-2019 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.
