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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 089 05 13 000 |
| Date submitted: |
5/26/2013 |
| Manufacturer: | Philips Medical Systems |
| Device Type: | Gamma Camera , Spect CT , Gemini and Precedence Systems utilizing Brilliance CT |
| Description: | Gamma Camera , Spect CT , Gemini and Precedence Systems utilizing Brilliance CT
CT , Brilliance CT , Brilliance iCT , Brilliance iCT SP
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| Medical Device Identifier: |
Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore.
Product Code(s): 882160, 882300, 882390, 882400, 882410,882412, 882470, 882473, 882471, 882476
Precedence SPECT /CT
Product Code(s): 882350, 882351
Brilliance CT (6, 10, 16, 16P, 40,64 and Big Bore), Brilliance iCT, Brilliance iCT SP
Product Code(s): 728256, 728251, 728246, 728240, 728235,728231, 728243, 728244, 728306, 728311
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| Reason of Field Safety Corrective Action: | The stated tolerance for CTDl 01 in the Instructions for Use Manual did not accurately represent all systems. On some systems the measured CTDl 01 value may fall outside of these stated tolerances. |
| Remedy Action: | Please find attached document titled ' PHILIPS ADDENDUM' Factors that Affect CTDl on Philips CT Systems. This information should clarify CTDI tolerances |
| Athorized Representative/Importer/Distributor: | Al-Faisaliah Medical System, Riyadh, (011) 2119948 |
| Report Source: | NCMDR |
| Source Ref. Number: | D495A08A562E9 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company |
| Attachments: |  Philips.pdf |
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