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Recall of Primary Antibodies to CD4 (clone 1F6), CD7 (clone LP15), Estrogen Receptor (clone 6F11), Leica Microsystems PDF, 349KB, File does not meet accessibility standards Date: 31. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 05999/11

Potential hazard associated with use of NIBP pump inside of monitor module, Spacelabs Medical PDF, 44KB, File does not meet accessibility standards Date: 31. January 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05884/11

Lot recall of Acetabular Low Profile Screw, BIOMET PDF, 36KB, File does not meet accessibility standards Date: 31. January 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05472/11

Field safety notice concerning a problem in Eclipse Version 10 with ARIAtm Radiation Oncology (RT Chart Module), Varian medical systems PDF, 406KB, File does not meet accessibility standards Date: 30. January 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 00170/12

Lot recall of LoFric Nelaton 20 cm CH10 urinary bladder catheters for single use, Astra Tech AB PDF, 841KB, File does not meet accessibility standards Date: 30. January 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00132/12

Recall of Triage 8 Panel for Drugs of Abuse Test Kit, Alere San Diego PDF, 118KB, File does not meet accessibility standards Date: 30. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00102/12

Recall of gabControl Strep A Test Cards, gabmed PDF, 106KB, File does not meet accessibility standards Date: 30. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04622/11

Software update for Brilliance CT Big Bore required, Philips PDF, 37KB, File does not meet accessibility standards Date: 27. January 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 00139/12

Problem with TrueBeam und TrueBeam STx, Varian medical systems PDF, 184KB, File does not meet accessibility standards Date: 27. January 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 00119/12

Corrective Action for Dade Actin FSL Activated PTT Reagent, Siemens PDF, 112KB, File does not meet accessibility standards Date: 27. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05829/11

Corrective action / recall for all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers, Instrumentation Laboratory PDF, 47KB, File does not meet accessibility standards Date: 27. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04496/10

Safety Notice concerning Coronary Analysis Software V1.10 of Scenaria device, Hitachi Medical Systems PDF, 127KB, File does not meet accessibility standards Date: 26. January 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 00101/12

Lot recall of SYNCHRON Systems Multi Calibrator Diskette, Beckman Coulter PDF, 130KB, File does not meet accessibility standards Date: 26. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06007/11

Safety Information concerning all RT300 FES cycles with software versions 3.05.061 or earlier, Restorative Therapies PDF, 29KB, File does not meet accessibility standards Date: 26. January 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Reference 05384/11

Lot recall of SOLIS Trial Cage, STRYKER PDF, 63KB, File does not meet accessibility standards Date: 26. January 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 05094/11

Safety Notice concerning TiBREEZE breast implants, pfm medical titanium GmbH PDF, 307KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00322/12

Field Safety Notice regarding Vital Signs enFlow IV Fluid Warmer Model 100, GE Healthcare PDF, 102KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 06044/11

Field safety notice concerning a possible risk in using connection fixture 1002.65A0 and 1002.65S0, Maquet Getinge Group PDF, 119KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03320/10

Field Safety Notice concerning Ingenuity CT systems with specific serial numbers, Philips PDF, 188KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 00040/12

Field Safety Notice concerning SKYLight Spect Systems, Philips PDF, 79KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 00042/12

Field Safety Notice concerning Patient Image mismatch and incorrect measurements/calculations on LOGIQ E9 Diagnostic Ultrasound System, GE Healthcare PDF, 60KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 00315/12

Batch recall of Red Cell Disposables, Haemonetics PDF, 41KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 00016/12

Lot recall of Antimicrobial Susceptibility Testing Discs AMC30 Amoxycillin / Clavulanic Acid, CT0223B, Thermo Fisher PDF, 76KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06022/11

Recall of CLINITEST hCG kit, Siemens Healthcare PDF, 23KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 05983/11

Problem with Pinnacle³ Software Version 9.0, Philips Healthcare PDF, 123KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 05936/11

Recall of any remaining model 1 or model 2 bronchial clamping adapters for 1.8 mm bronchial catheter, Varian medical systems PDF, 188KB, File does not meet accessibility standards Date: 25. January 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 05928/11

Corrective Action for ARCHITECT Active-B12, Abbott PDF, 28KB, File does not meet accessibility standards Date: 20. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00021/12

Recall of numerous lots of T2 Arthrodesis Nail, STRYKER PDF, 105KB, File does not meet accessibility standards Date: 20. January 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00199/12

Corrective action for the Elecsys 2010 analyzer (Software Version 06-07 or below), Roche Diagnostics PDF, 207KB, File does not meet accessibility standards Date: 20. January 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06043/11

Field Safety Notice concerning a corrective action of Mobile Workstation WM-P1 Series, Olympus KeyMed PDF, 185KB, File does not meet accessibility standards Date: 19. January 2012 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04142/11