Mindray recalls Gas Module 3 spirometers (part 115-030108-00) purchased between Feb 2008 and Oct 2015 due to regulatory changes requiring new safety approvals. This update ensures continued safe use in medical settings.
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Mindray is recalling Gas Module 3 spirometers with part number 115-030108-00 that were purchased between February 2008 and October 2015. The recall is due to regulatory changes that require updated safety approvals for these medical devices.
The device requires updated safety approvals after regulatory changes. This update ensures continued safe use in medical settings without posing a risk of injury during normal operation.
Healthcare providers using the Gas Module 3 in operating rooms or intensive care units who purchased it between February 2008 and October 2015 are affected. Patients receiving anesthesia or assisted respiration using this device may also be impacted.
Check for part number 115-030108-00 on the Gas Module 3 spirometer. The device was purchased between February 14, 2008, and October 2015.
Verify the part number on the Gas Module 3 spirometer to confirm if it falls within the recall range.
The recall is due to regulatory changes requiring updated safety approvals for the Gas Module 3 spirometer after the firm submitted a new 510(k) premarket notification.
No, the device can continue to be used safely as the recall involves regulatory updates, not a safety hazard.
Check the part number to confirm if it is affected; no action is needed if it is outside the recall range.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-1242-2018 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-1242-2018 from Mindray. 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.
