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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
All units of Model numbers 455011203131 and 455011203191.
Products Sold
All units of Model numbers 455011203131 and 455011203191.
Philips Medical Systems (Cleveland) Inc is recalling Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncol due to Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correla. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026