Device Recall Philips

System Code: 882480;  Serial #s: 4000224, 4000061, 4000321, 4000043, 4000065, 4000081, 4000180, 4000044, 4000527, 4000298, 4000229, 4000262, 4000378, 4000280, 4000336, 4000324, 4000184, 4000190, 4000516, 4000303, 4000411, 4000305, 4000009, 4000012, 4000413, 4000213, 4000335, 4000436, 4000500, 4000491, 4000510, 4000518, 4000418, 4000454, 4000197, 4000353, 4000469, 4000005, 4000042, 4000379, 4000533, 4000451, 4000137, 4000343, 4000030, 4000540, 4000421, 4000342, 4000495, 4000511, 4000317, 4000338, 4000316, 4000408, 4000251, 4000031, 4000341, 4000122, 4000530, 4000395, 4000286, 4000294, 4000348, 4000296, 4000462, 4000463, 4000464, 4000419, 4000096, 4000476, 4340005, 4000484, 4000268, 4000382, 4000169, 4000447, 4000228, 4000442, 4000297, 4000047, 4000049, 4000488, 4000156, 4000412, 4000273, 4000337, 4000394, 4000194, 4000179, 4000401, 4000385, 4000504, 4000121, 4000109, 4000115, 4000257, 4000503, 4000105, 4000356, 4000333, 4000339, 4000107, 4000227, 4000233, 4000173, 4000400, 4000397, 4000398, 4000494, 4000256, 4000386, 4000168, 4000126, 4000154, 4000399, 4000272, 4000478, 4340004, 4000219, 4000243, 4000437, 4000376, 4000416, 4000485, 4000035, 4000515, 4000427, 4000142, 4000226, 4000519, 4000475 4000066, 4000183, 4000459, 4000461, 4000468, 4000210, 4000063 4000150, 4000217, 4000393, 4000420, 4000479, 4000300, 4000075, 4000080, 4000086, 4000013, 4000396, 4000481, 4000392, 4000157, 4000323, 4000374, 4000072, 4000237, 4000493, 4000354, 4000203, 4000167, 4000041, 4000407, 4000372, 4000133, 4000209, 4000299, 4000477, 4000314, 4000010, 4000539, 4000409, 4000134, 4000153, 4000373, 4000471, 4000163, 4000465, 4000082, 4000331, 4000282, 4000449, 4000216, 4000269, 4000415, 4000345, 4000208, 4000279, 4000254, 4000125, 4000201,

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

Philips brand BrightView Gamma Camera System, || SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; || Product is manufactured and distributed by || Philips Medical Systems (Cleveland), Inc., || Cleveland, OH || The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel

System Code: 882480;  Serial #s: 4000224, 4000061, 4000321, 4000043, 4000065, 4000081, 4000180, 4000044, 4000527, 4000298, 4000229, 4000262, 4000378, 4000280, 4000336, 4000324, 4000184, 4000190, 4000516, 4000303, 4000411, 4000305, 4000009, 4000012, 4000413, 4000213, 4000335, 4000436, 4000500, 4000491, 4000510, 4000518, 4000418, 4000454, 4000197, 4000353, 4000469, 4000005, 4000042, 4000379, 4000533, 4000451, 4000137, 4000343, 4000030, 4000540, 4000421, 4000342, 4000495, 4000511, 4000317, 4000338, 4000316, 4000408, 4000251, 4000031, 4000341, 4000122, 4000530, 4000395, 4000286, 4000294, 4000348, 4000296, 4000462, 4000463, 4000464, 4000419, 4000096, 4000476, 4340005, 4000484, 4000268, 4000382, 4000169, 4000447, 4000228, 4000442, 4000297, 4000047, 4000049, 4000488, 4000156, 4000412, 4000273, 4000337, 4000394, 4000194, 4000179, 4000401, 4000385, 4000504, 4000121, 4000109, 4000115, 4000257, 4000503, 4000105, 4000356, 4000333, 4000339, 4000107, 4000227, 4000233, 4000173, 4000400, 4000397, 4000398, 4000494, 4000256, 4000386, 4000168, 4000126, 4000154, 4000399, 4000272, 4000478, 4340004, 4000219, 4000243, 4000437, 4000376, 4000416, 4000485, 4000035, 4000515, 4000427, 4000142, 4000226, 4000519, 4000475 4000066, 4000183, 4000459, 4000461, 4000468, 4000210, 4000063 4000150, 4000217, 4000393, 4000420, 4000479, 4000300, 4000075, 4000080, 4000086, 4000013, 4000396, 4000481, 4000392, 4000157, 4000323, 4000374, 4000072, 4000237, 4000493, 4000354, 4000203, 4000167, 4000041, 4000407, 4000372, 4000133, 4000209, 4000299, 4000477, 4000314, 4000010, 4000539, 4000409, 4000134, 4000153, 4000373, 4000471, 4000163, 4000465, 4000082, 4000331, 4000282, 4000449, 4000216, 4000269, 4000415, 4000345, 4000208, 4000279, 4000254, 4000125, 4000201,

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

Philips brand BrightView Gamma Camera System, || SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801; || Product is manufactured and distributed by || Philips Medical Systems (Cleveland), Inc., || Cleveland, OH || The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

System Code: 882480;  Serial #s: 4000224, 4000061, 4000321, 4000043, 4000065, 4000081, 4000180, 4000044, 4000527, 4000298, 4000229, 4000262, 4000378, 4000280, 4000336, 4000324, 4000184, 4000190, 4000516, 4000303, 4000411, 4000305, 4000009, 4000012, 4000413, 4000213, 4000335, 4000436, 4000500, 4000491, 4000510, 4000518, 4000418, 4000454, 4000197, 4000353, 4000469, 4000005, 4000042, 4000379, 4000533, 4000451, 4000137, 4000343, 4000030, 4000540, 4000421, 4000342, 4000495, 4000511, 4000317, 4000338, 4000316, 4000408, 4000251, 4000031, 4000341, 4000122, 4000530, 4000395, 4000286, 4000294, 4000348, 4000296, 4000462, 4000463, 4000464, 4000419, 4000096, 4000476, 4340005, 4000484, 4000268, 4000382, 4000169, 4000447, 4000228, 4000442, 4000297, 4000047, 4000049, 4000488, 4000156, 4000412, 4000273, 4000337, 4000394, 4000194, 4000179, 4000401, 4000385, 4000504, 4000121, 4000109, 4000115, 4000257, 4000503, 4000105, 4000356, 4000333, 4000339, 4000107, 4000227, 4000233, 4000173, 4000400, 4000397, 4000398, 4000494, 4000256, 4000386, 4000168, 4000126, 4000154, 4000399, 4000272, 4000478, 4340004, 4000219, 4000243, 4000437, 4000376, 4000416, 4000485, 4000035, 4000515, 4000427, 4000142, 4000226, 4000519, 4000475 4000066, 4000183, 4000459, 4000461, 4000468, 4000210, 4000063 4000150, 4000217, 4000393, 4000420, 4000479, 4000300, 4000075, 4000080, 4000086, 4000013, 4000396, 4000481, 4000392, 4000157, 4000323, 4000374, 4000072, 4000237, 4000493, 4000354, 4000203, 4000167, 4000041, 4000407, 4000372, 4000133, 4000209, 4000299, 4000477, 4000314, 4000010, 4000539, 4000409, 4000134, 4000153, 4000373, 4000471, 4000163, 4000465, 4000082, 4000331, 4000282, 4000449, 4000216, 4000269, 4000415, 4000345, 4000208, 4000279, 4000254, 4000125, 4000201,

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

Philips brand BrightView Gamma Camera System, || SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811; || Product is manufactured and distributed by || Philips Medical Systems (Cleveland), Inc., || Cleveland, OH || The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

Serial Numbers 525 539 146 155 171 173 178 611 612 150 165 231 234 175 235 236 237 238 239 240 356 376 389 414 000475 483 000496 502 510 511 686 693 700 723 724 725 167-000385 167-000487 232 000372, and 000834.

Anesthesiology Devices

2

No

Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.

FloTrak Elite modules || FloTrak Elite P/N 1044971 || FloTrak Elite P/N 1051005

Software releases: PBL 6.5.1 1PBL 6.5.2 1PBL 7.0.x 1PBL 7.2.x

Radiology Devices

2

No

Nationwide Distribution

Allura Xper Systems Models: || Allura Xper FD10 (F/C)-Biplane Fixed || Allura Xper FD10/10 (incl. OR table) || Allura Xper FD20- High resolution fixed-x ray || Allura Xper FD20/10 || Allura Xper FD20/20 || Allura CV20 || The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)