Medical Devices

Medical device safety information

The manufacturer or authorised representative of the manufacturer of a medical device must notify the Agency for Medicinal Products and Medical Devices in writing of any corrective action it intends to carry out in order to reduce as far as possible the possibility of a recurrence of an adverse incident concerning the medical device.

In addition to notifying the Agency, the manufacturer or authorised representative of the manufacturer of a medical device must notify users about the corrective action by providing safety information using a method that guarantees that all users are notified. The safety information should be in Croatian language and include the elements set out in Annex III of the Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13).

We present received safety information notifications below.

Recall of CooperVision Proclear toric contact lenses

08.10.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received from a medical device manufacturer CooperVision, England, a notification on the recall of the medical device Proclear toric contact lenses.Taking account that there is no risk for users, the recall of the batches 100375500080080717, 104235500040220516 and 104275000160220117 is being carried out at the retail level.

Detailed information is accessible under the link below.

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ORTHO BioVue System Cassette immunohematology

05.02.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer Ortho Clinical Diagnostics, England, an information about the addendum to the safety corrective action regarding the ORTHO BioVue System Cassette for immunohematology.

The manufacturer has provided users with the revised risk assessment and table of possible impact on test results.

Detailed information is available under the following link.

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Roche Diagnostics GmbH – OMNI Micro referent electrode

05.02.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer Roche Diagnostics GmbH an information about the omission in the instructions for use. Namely, the maximal life cycle of 52 weeks of reference electrodes on diagnostic systems Roche OMNI C, Roche OMNI S, cobas b 221, b121 and b121.
The manufacturer has advise users to replace the referent electrode if it is older than 52 weeks and will provide a new version of software support including a reminder for electrode replacement.

The complemented version of the instructions for use will be delivered to users.

Detailed information is available under the link below.

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Medtronic Mosaic Aortic Prosthesis

23.01.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Medtronic Inc. on the change of the iEOA table and size measuring device for Mosaic aortic bioprosthesis of the model 305 due to reports to higher than expected transvalvular gradients occurred after implantation.

The manufacturer has informed users that older versions of tables and measuring device will not be distributed anymore.

Detailed information is accessible under the following link.

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Zimmer GmbH, Switzerland - Manual for orthopedic surgical instruments - Instructions for care, cleaning, maintenance and sterilisation of Zimmer instruments

23.01.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Zimmer, GmbH on the change in cleaning and sanitation of Zimmer othopedic surgical instruments.

The manufacturer has amended Instructions for care, maintenance and sterilisation of Zimmer instruments in chapters 8F, 8I and 11 of the Manual for orthopaedic surgical instruments.

Detailed information is accessible under the link below.

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Datex-Ohmeda, Inc. - anesthesiological apparatus Aisys, Avance, Amingo, Aespire and Aestiva

17.01.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Datex-Ohmeda, Inc. (GE Healthcare) reminding users on the importance of occasional device shutdown/restarting and self-testing at restarting.

The manufacturer reminds users that devices start alarm for shutdown/restarting due to self-testing, if devices work continuously longer than 12 hours and may stop working if they are continuously on longer than 49 days.

Detailed information is available under the following link.

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Carestream Health, Inc. - Kodak 2100 and Kodak 2200 system for oral Rontgen

15.01.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Carestream Health, Inc. on the possibility of an earlier damage on the junction of scissors arm holder in intraoral Röntgen systems Kodak 2100 and Kodak 2200.

The manufacturer has discovered the problem on devices delivered in the time period between May 2008 and April 2010 and advises users to check the devices for damage signs even before visit to service engineers.

Detailed information is accessible under the following link.

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