Recall Z-0679-2024
Philips North America · initiated November 30, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BrightView XCT, Gamma Camera, Product Code 882482
Codes / lots: No UDI Serial numbers 7811_12 6000374 6000199 6000219 6000012 6000123 6000065 6000051 6000084 6000351 6000259 6000212 6000337 6000302 6000144 6000193 6000068 6000075 6000385 6000027 6000124 600009 6000176 6000260 6000298 6000189 6000040 6000140 6000146 6000197 6000408 6000401 6000104 6000289 6000306 6000304 6000022 6000015 6000163 11000021 6000325 6000021 6000056 6000060 6000057 6000026 6000054 6000033 6000089 6000094 6000053 6000082 6000165 6000164 6000167 6000194 6000171 6000203 6000195 6000204 6000220 6000229 6000228 6000237 6000235 6000206 6000295 6000318 6000317 6000349 6000352 6000355 6000396 6000391 6000402 6000020 6000037 6000047 6000077 6000130 6000147 6000128 6000184 6000131 6000132 6000210 6000251 6000269 6000310 6000309 6000416 6000338 6000330 6000339 6000109 6000115 6000126 6000276 6000025 6000029 6000036 6000013 6000038 6000045 6000173 6000006 6000083 6000081 6000086 6000215 6000074 6000113 6000072 6000078 6000090 6000070 6000186 6000188 6000185 6000174 6000127 6000159 6000182 6000183 6000201 6000187 6000236 6000234 6000246 6000296 6000334 6000332 6000368 6000370 6000380 6000035 6000111 6000059 6000097 6000192 6000258 6000278 6000376 6000379 6000363 6000406 6000121…
Reason for recall
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
FDA-determined cause: Device Design
Action taken
On November 30, 2023, the firm notified customers of the issue through Urgent Medical Device Correction Letters. Users were instructed to monitor the patient during system movement when Pre-Programed Motion is in use and review the warning and caution guidance information provided with the recall notice, and which is also outlined in the Instructions for Use. Philips will contact you to schedule a time for a field service engineer to visit your site and install a technical solution to resolve this issue. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Details
- Recall number
- Z-0679-2024
- Initiated
- November 30, 2023
- Posted by FDA
- January 5, 2024
- Product code
- KPS – System, Tomography, Computed, Emission
- Quantity
- 135 US; 294 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recalling firm
- Philips North America, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0677-2024 Class II | BrightView, Gamma Camera System, Product Code 882480.While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the… | 11/30/2023Open, Classified |
| Z-0678-2024 Class II | BrightView X, Gamma Camera, Product Code 882478While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the… | 11/30/2023Open, Classified |