Compass Health recalls MediPress pneumatic compression system Model 6104S-S due to missing premarket clearance. All units are affected. No specific action steps provided in recall notice.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Compass Health is recalling all MediPress Full Arm (Short)-Segmental Gradient compression systems with model number 6104S-S because they were designed without proper premarket clearance. This could lead to safety issues if used without regulatory approval.
The device was designed without proper premarket clearance, meaning it did not undergo the required regulatory review before being sold. This could result in safety issues if the device is used without the necessary approvals.
Healthcare providers using this medical device are likely affected. Patients receiving treatment with this device may be at risk if the device is not properly cleared by regulators.
Check for the model number 6104S-S on the device. All serial numbers and lots are affected by this recall.
Look for the model number 6104S-S on the device to confirm it is affected.
The device was designed without proper premarket clearance, meaning it did not undergo the required regulatory review before being sold.
The recall notice does not specify any action steps for affected devices.
The recall notice does not describe specific injury risks, only that the device lacks proper regulatory clearance.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1348-2019 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1348-2019 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.
