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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 11 Results
510(K) Number: K010435
 
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FDA Recall
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BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system... 2 12/09/2021 Philips North America Llc
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system... 2 12/09/2021 Philips North America Llc
Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic... 2 10/27/2011 Philips Healthcare Inc.
Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage... 2 10/27/2011 Philips Healthcare Inc.
Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage:... 2 10/27/2011 Philips Healthcare Inc.
Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluorosco... 2 03/08/2011 Philips Medical Systems North America Co. Phillips
Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoro... 2 03/08/2011 Philips Medical Systems North America Co. Phillips
Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-r... 2 10/25/2010 Philips Medical Systems North America Co. Phillips
Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X... 2 10/25/2010 Philips Medical Systems North America Co. Phillips
Philips BV Pulsera Mobile X-Ray system with the extended rotation option. 2 09/22/2010 Philips Medical Systems North America Co. Phillips
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