One Cat. Life Pulse High Frequency Ventilator, Catalog… recallZ-0902-2011 · Bunnell, Inc. · initiated Oct 25, 2010
Terminated All recalls posted in January 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bunnell, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product software coding error may compromise patient safety.
FDA root cause category: Software design
What the company is doing
Customers were notified by an "Urgent: Medical Device Recall or Correction" letter starting 10/22/10. The letter identified the product and described the issues. Customers were given the option of either returning their ventilator(s) for rework or to receive installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for the software upgrade.
Recall details
- Recall number
- Z-0902-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 25, 2010
- Posted by the FDA
- Jan 14, 2011
- Recalling firm
- Bunnell, Inc.
- Quantity
- 660 total
- Product code
- LSZ
- FDA submissions
- P850064
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
Product description
One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
Code information (models, lots, serial numbers)
Model 203
Other devices under the same FDA submission
3 devices cleared under P850064 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Bunnell 903Bunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- LifePort 2.5 mmBunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- LifePulse 312Bunnell, Incorporated · Ventilator, High Frequency1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 57377).
- Z-0901-2011 · TerminatedOne Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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