“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
Philips HeartStart MRx cardiac monitor / defibrillator, model number: M3536A with R.03.03 software and 12 Lead option (manual defibrillator)Model number: M3536A with R.03.03 software and 12 Lead option (or with the capability to install 12 lead option)Manufactured between April 17 2012 and May 8 2012Multiple serial numbersARTG number: 95661
Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5 and M3536M6 (manual defibrillator)All units manufactured prior to June 2012 (Model / manufacture date is printed on the primary label on the back of battery bay B)ARTG Number: 95661
PAD 300/PAD 300P Public Access Defibrillators (PAD) (Semi-automated defibrillator)Affected serial numbers: 0400000501 to 0700032917, 08A00035000 to 10A0070753 & 10C00200000 to 10C00210318Manufactured between August 2004 and December 2010ARTG Number: 156690
HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).Units Affected: HeartStart XL battery M3516A labelled with 'Made in Taiwan' and date of manufacture 'R-2011-12'ARTG Number : 95661