Compass Health recalls MediPress pneumatic compression systems with model #6102-S due to missing premarket clearance. Affected units may not be safe for medical use without regulatory approval.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Compass Health is recalling MediPress pneumatic compression systems with model #610: Half Leg-Segmental Gradient, serial numbers/lots. This recall happens because the product design change didn't get proper premarket regulatory approval, which could mean it's unsafe for medical use.
The product design change did not receive proper premarket clearance, meaning it might not meet safety standards. Without regulatory approval (510(k)), the device could pose risks during medical use.
Medical facilities using the MediPress system with model #6102-S are likely affected. Patients receiving treatment with this device could be at risk if it's not properly cleared by regulators.
Check for the model number 6102-S on the MediPress system. All serial numbers and lots are affected by this recall. The product is a half leg-segmental gradient pneumatic compression system.
Identify the model number on the MediPress system to confirm if it's 6102-S.
The product design change did not receive proper premarket clearance and lacks a 510(k), which could mean it's unsafe for medical use.
The recall record does not specify a remedy, so check with Compass Health directly for guidance.
The recall record does not describe specific injury risks, so the danger level is unknown.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1343-2019 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1343-2019 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.
