FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
- Recall number
- Z-0132-2009
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
- Status
- Terminated
- Initiated
- 2008-09-22
- Posted
- 2008-10-28
- Terminated
- 2012-03-01
- Reason
- Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correlated images.
- Root cause
- Process design
- Action
- On 9/8/2008 Philips Medical Systems sent recall notification letters to their customers requesting they inventory their stock. They sent instructions to verify that the product is working properly. They are also sending Field Service Engineers to each customer to conduct field test.
- Quantity
- 507 units
- Distribution
- Worldwide distribution: USA, Australia, Austria, Bahrain, Belgium, Canada, China, Czech Republic, Denmark, England, Finland, France, Germany, Israel, Italy, Japan, Jordan, Korea, Lithuania, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, South Africa, Saudi Arabia, Spain, Switzerland, Sweden, and Thailand.
- Lot, serial or model codes
- All units of Model numbers 455011203131 and 455011203191.
- 510(k) numbers
- ["K012009","K033326","K033357"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28