Field Corrective Actions
Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, and to advise on what action should be taken to protect the health or the safety of patients, users or other persons. For example, advisory notices may contain the information from the manufacturer that he voluntarily recalls a medical device.
RSS-Feed of Field Corrective Actions
Please note that advisory notices are issued by the manufacturer, the authorized representative or the importer of medical devices. The respective company takes the responsibility for all information given in the advisory notice.
Search results 1 to 25 from a total of 96 (4 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2012.02.10 | 5051/11 |
Issue with Mosaiq upon import of treatment plan, Elekta Elekta has discovered an issue that potentially affects any treatment field defined with MLC leaves at the time of RTP import of treatment plans. A defect in Mosaiq truncates the MLC Leaf values upon the import of a treatment plan after the 3D Image Viewer has been opened, if the workstation on which the import was executed is configured to use a Comma (,) as the decimal separator.
|
Radiotherapy/ Radiation protection |
| 2012.02.09 | 0479/12 |
Amendment of instructions for use of Advansys® Medical Lisfranc Plates, Newdeal SAS / France The manufacturer Newdeal SAS / France became aware of several incidents describing the rupture of the tibialis anterior tendon after implantation of the device Advansys® Medical Lisfranc Plates. The instructions for use have been amended.
|
Non-active implants |
| 2012.02.09 | 0344/12 |
Recall of Certain® low profile 17° angled abutment, BIOMET 3i Recall of Certain® low profile 17° angled abutment produced by the company BIOMET 3i. The action was initiated because of a packaging error. Please see the attached customer notice to learn about the concerned catalogue and lot numbers.
|
Dental products |
| 2012.02.09 | 4192/11 |
Revision of directions for use concerning Wingspan® Stent with Gateway® PTA Balloon Catheter, BOSTON SCIENTIFIC BOSTON SCIENTIFIC informed customers about the revision of the directions for use concerning the product Wingspan® Stent with Gateway® PTA Balloon Catheter. The addition of details on the therapeutic indication ensures that the direction for use is consistent with the current standards of care.
|
Non-active implants |
| 2012.02.07 | 5929/11 |
Corrective Action for TANGO optimo pipetting system, BioRad Corrective Action of BioRad for TANGO optimo pipetting system due to a technical error. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.02.06 | 0380/12 |
Lot recall of Accolade Rasp handle assembly, Stryker Orthopaedics Mahwah Stryker Orthopaedics Mahwah recalls one lot number of the Accolade Rasp handle assembly, catalogue numbers 1020 - 1400 because of a deviation in the manufacturing process.
|
Medical instruments |
| 2012.02.06 | 0329/12 |
Field safety notice concerning incorrect position readout values, Varian medical systems Varian medical systems has issued a field safety notice concerning incorrect position readout values caused by excessive connector resistance of C-Series Clinac or Trilogy, version 7.x und 8.x.
|
Radiotherapy/ Radiation protection |
| 2012.02.06 | 0100/12 |
Field Safety Notice regarding the COstatus AV Loop, Transonic Systems Transonic Systems has issued a Field Safety Notice regarding the COstatus AV Loop. The user has to follow the AV Loop Quality Check.
|
Medical electronics / Electromedical devices |
| 2012.02.06 | 0022/12 |
Field Safety Notice regarding SERVO-I and SERVO-s ventilators, Maquet Maquet has issued a Field Safety Notice regarding SERVO-I and SERVO-s ventilators. There is a risk to get an electric shock from the AC/DC converter during service of the ventilator.
|
Surgical equipment/ Anaesthesia |
| 2012.02.06 | 0018/12 |
Field safety notice concerning Lifeguard trolleys (stretchers) LG20 (all variants) and LG50 (all variants), ARJOHUNTLEIGH Medical Beds Division The company ARJOHUNTLEIGH Medical Beds Division has issued a field safety notice concerning the Lifeguard trolleys (stretchers) LG20 (all variants) and LG50 (all variants). There is the risk of a breakage of the plastic side rail hinges in normal use.
|
General equipment for medical treatment |
| 2012.02.06 | 6035/11 |
Lot recall of Handi-Fill Disposable Syringe Fill Tube, article 302050MKG, Covidien The distributor Covidien recalls several lot numbers of the Handi-Fill Disposable Syringe Fill Tube, article 302050MKG, manufactured by Liebel Flarsheim. The primary sterile packaging may be compromised.
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Injection/ Infusion/ Transfusion/Dialysis |
| 2012.02.06 | 5781/11 |
Potential for gantry collisions of Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ accelerators, Varian medical systems Varian medical systems has issued a field safety notice concerning potential for gantry collisions during remote motion of Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ accelerators.
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Radiotherapy/ Radiation protection |
| 2012.02.06 | 5415/11 |
Product issue related to the CO2 sampling lines, Oridion Oridion notifies customers of a product issue related to the CO2 sampling lines. Oridion discovered that the connector may cause breakage of the microswitch inside the CO2 inlet of the Welch Allyn capnograph.
|
Medical electronics / Electromedical devices |
| 2012.02.06 | 5035/11 |
Additional Lot-No. on recall of Lupine Loop Anker, DePuy One additional Lot-No. has been added on the recall of Lupine Loop Anker by the manufacturer DePuy. The action was initiated because of an incorrect assembly of the thread loop.
|
Non-active implants |
| 2012.02.03 | 5962/11 |
Recall MAS CardioImmune XL, Thermo Fisher Recall of Thermo Fisher for MAS CardioImmune XL – Liquid Assayed Cardiac Marker Control (lot numbers: CXL1301L,CXL13011,CXL13012,CXL13013,CXL13014,CXL1301S) due to a control measurement which may be approximately 15-30 % below published ranges. Customers were informed.
|
In-vitro diagnostics |
| 2012.02.03 | 3031/11 |
Lot recall of orthodontic brackets Spirit MB, ORMCO Spirit MB Brackets:
|
Dental products |
| 2012.02.03 | 0286/12 |
Hardware updates required for Discovery NM/CT 670 SPECT/CT and Discovery NM 630 SPECT Systems, GE Healtcare GE Healtcare has issued a Field Safety Notice concerning hardware updates required for Discovery NM/CT 670 SPECT/CT and Discovery NM 630 SPECT Systems.
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Radiological technology |
| 2012.02.03 | 0245/12 |
Recall of SLIDEX Staph-Kit, bioMerieux Recall of bioMerieux for SLIDEX Staph-Kit (Lot No.: 1105104568 and 1105104545) due to false negative results with Staphylococcus aureus. Customers were informed.
|
In-vitro diagnostics |
| 2012.02.03 | 0236/12 |
Batch recall of Connectable Radio-Opaque Pushers, Coloplast Coloplast is conducting a recall of one batch of Connectable Radio-Opaque Pushers which are included in different Ureteral Stent sets. Reasons for the recall were dimensional deviations which can lead to difficulties or make it impossible to disconnect pushers from stents after use.
|
Non-active implants |
| 2012.02.03 | 0201/12 |
DUET TRS Loading units (SOLU) devices not to use in thoracic surgery, Covidien Covidien informs users of the DUET TRS Loading units (SOLU) these devices not to use in thoracic surgery. The manufacturer has received several reports of serious injuries and deaths following the application of the devices in the thoracic cavity.
|
Medical instruments |
| 2012.02.02 | 5484/11 |
Recall of OneTouch Zoom Pro Diabetes Management Software, Lifescan Recall of Lifescan for the OneTouch Zoom Pro Diabetes Management Software due to incorrect alert information. The software will be upgraded.
|
In-vitro diagnostics |
| 2012.02.02 | 0335/12 |
Lot recall of Bravo pH Monitoring devices, Given Imaging Given Imaging has issued a Field Safety Notice concerning a recall of Bravo pH Monitoring devices (part number FGS-0312 and FGS 0313) with lot numbers 11775Q to 17101Q. The manufacturer has received reports of failure of the Bravo capsule to attach to the oesophagus.
|
Optics / Precision mechanics |
| 2012.02.02 | 0071/12 |
Recall of Afinion CRP, Axis-Shield Recall of Axis-Shield for Afinion CRP due to incorrect results in newborn infants. Customers were informed.
|
In-vitro diagnostics |
| 2012.02.02 | 5996/11 |
Field Safety Notice concerning surgical lights model Hanaulux G8, Maquet S.A.S. Maquet S.A.S. has issued a Field Safety Notice concerning a corrective action of the spring arms of the surgical lights model Hanaulux G8. The rear joint may break and as result the support plate could become loose and the spring arm drop down. The weld seams of each Hanaulux G8 spring arms will be verified and upgraded by trained technical specialists authorized by Maquet.
|
Surgical equipment/ Anaesthesia |
| 2012.02.01 | 0334/12 |
Potential malfunction when using syngo.plaza VA20B_HF04, Siemens Healthcare Siemens Healthcare has issued a field safety notice concerning a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license.
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Radiological technology |
