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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 184 12 13 003 |
| Date submitted: |
1/2/2014 |
| Manufacturer: | Stryker Medical |
| Device Type: | Medical/Surgical Beds, Various S3 and Secure II Medical/Surgical Beds. |
| Description: | Beds, Electric |
| Medical Device Identifier: | Medical/Surgical Beds: S3, Secure II.
Model Numbers:
-3002 S3 EX, 3002 S3 CUSTOM, 3002 S3 PATRIOT, 3002 SE SIGNATURE, 3002 S2 ZOOM.
-3002000000, 3002 EX, 3002 CUSTOM, 3002 KCI, 3002 ZOOM, 3002 ZX-SB.
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FDA update codes :
Serial Numbers: 080615942, 080715062, 080916706, 080916707, 080916708, 080916709, 080916710, 080916711, 080916712, 080916713…….. See attached PDF |
| Reason of Field Safety Corrective Action: | Foot-End Cover and Power Coil Cable May Be Damaged. |
| Remedy Action: | Locate and inspect the beds listed in this notice and ensure that no damage has occurred to the Foot End Cover, Power Coil Cable, or Sensor Coil Cable
a. If no damage has occurred, you may continue to use the bed.
b. If damage has occurred to the Foot End Cover and/or Power Coil Cable and/or Sensor Coil Cable, please remove the bed from service and contact your authorized Stryker distributor to arrange a service.
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| Athorized Representative/Importer/Distributor: | Al-Jeel Medical & Trading Co. LTD, (011) 4041717 |
| Report Source: | NCMDR |
| Source Ref. Number: | E006225AAC20E |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Stryker Medical code information.pdf |
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