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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 002 07 18 000 |
| Date submitted: |
7/1/2018 |
| Manufacturer: | Beekley |
| Device Type: | S-SPOT, Tomo-SPOT, O-SPOT |
| Description: | Mammography Skin Makers |
| Medical Device Identifier: | REF No.: 777, 7775, 782, 782S, 783, 783S, 784, 784S, 785, 785S, 791, 791S |
| Reason of Field Safety Corrective Action: | Two customer complaints (COMP-00324 and COMP-00336) have been received of artifact with O-SPOT REF 791. Some patients have been re-imaged due to artifact. The cause of the artifact appears to be the raw material used in the Designed for Digital material to produce the REF 777, 777S, 782, 782S, 783, 783S, 784, 784S, 785, 785S, 791, 791S |
| Remedy Action: | A recall was initiated on June 14, 2018 |
| Athorized Representative/Importer/Distributor: | Bio Standards |
| Report Source: | NCMDR |
| Source Ref. Number: | A08BC566DB331 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Beekley Corporation.pdf |
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