| MDA-2017-037 |
21 December 2017 |
AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop |
| MDA-2017-036 |
20 December 2017 |
Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion |
| MDA-2017-035 |
19 December 2017 |
Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap |
| MDA-2017-034 |
23 November 2017 |
ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc – potential for false resistance results if stored at the wrong temperature |
| MDA-2017-033 |
03 October 2017 |
Professional use HIV test: Alere HIV Combo – risk of false positive results |
| MDA-2017-032 |
03 October 2017 |
Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients |
| MDA-2017-031 |
29 September 2017 |
Philips Healthcare: IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected. |
| MDA-2017-030 |
20 September 2017 |
All Accu-Chek® Insight insulin pumps – risk of alarm failure |
| MDA-2017-029 |
12 September 2017 |
Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery |
| MDA-2017-028 |
31 August 2017 |
Replacement bileaflet mechanical heart valves – risk of inverted implantation |
| MDA-2017-027 |
24 August 2017 |
Intra-Aortic Balloon Pump (IABP) – risk of hemodynamic instability to patients |
| MDA-2017-026 |
24 August 2017 |
Prism - Freeway Easy Fit system with a swivelling trolley – risk of fixing pin moving or splaying |
| MDA-2017-025 |
24 August 2017 |
Zimmer Biomet - Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection |
| MDA-2017-024 |
24 August 2017 |
Novo Nordisk NovoPen Echo & NovoPen 5 – Risk of hyperglycaemia |
| MDA-2017-023 |
18 August 2017 |
Shoulder System: Comprehensive Nano Humeral Components - Increased Risk of Revision when Used in Reverse Configeration |
| MDA-2017-022 |
17 August 2017 |
DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection |
| MDA-2017-021 |
14 August 2017 |
VITEK®2 Identification (ID)/Antimicrobial Susceptibility Test (AST) Cards - Potential False Resistance for Antibiotics on the AST Panel, leading to false negative ESBL Test or False Positive Urea (URE) Reaction in ID Cards |
| MDA-2017-020 |
11 July 2017 |
Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant |
| MDA-2017-019 |
10 July 2017 |
Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask |
| MDA-2017-018 |
29 June 2017 |
All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients |
| MDA-2017-017 |
21 June 2017 |
Intersurgical - BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment |
| MDA-2017-016 |
12 June 2017 |
DePuy-Synthes Radial Head Elbow Prosthesis System, Risk of Post-Operative Loosening of Radial Stem |
| MDA-2017-015 |
09 June 2017 |
Solus Laryngeal Mask Airway – risk of partial or total occlusion of the airway after inflating cuff |
| MDA-2017-014 |
24 May 2017 |
All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring |
| MDA-2017-013 |
18 May 2017 |
All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy. |
| MDA-2017-012 |
17 May 2017 |
V60 ventilator – potential for unexpected shutdown |
| MDA-2017-011 |
03 May 2017 |
Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration |
| MDA-2017-010 |
02 May 2017 |
All Accu-Chek® Insight insulin pumps – updated information for battery management |
| MDA-2017-009 |
24 April 2017 |
BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy |
| MDA-2017-008 |
24 April 2017 |
Teleflex - Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia |
| MDA-2017-007 |
21 April 2017 |
Teleflex - LMA MAD Nasal intranasal mucosal atomization device – might not deliver a fully atomised plume of medication |
| MDA-2017-006 |
12 April 2017 |
All Alaris ™ GS, GH, CC, TIVA, PK, enteral syringe pumps & Asena™ GS, GH, CC, TIVA, PK, syringe pumps – risk of uncontrolled bolus of medicine |
| MDA-2017-005 |
04 April 2017 |
Comprehensive Reverse |
| MDA-2017-004 |
07 March 2017 |
CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks. |
| MDA-2017-003 |
20 February 2017 |
Alaris Syringe Pumps (GH, CC, TIVA & PK Models) – Risk of Uncontrolled Bolus of Medicine |
| MDA-2017-002 |
17 February 2017 |
Reflection Dead Blow Mallet (All Batches) – Risk of Exposure to Lead Particles |
| MDA-2017-001 |
08 February 2017 |
Oxylog 3000 and Oxylog 3000 Plus Ventilator - Risk of Failure |
| MDA-2016-0023 |
22 December 2016 |
Alaris syringe pumps (all models) – risk of uncontrolled bolus of medicine with non-recommended syringes. |
| MDA-2016-0022 |
13 December 2016 |
Heater-cooler devices used in cardiac surgery - risk of infection with Mycobacterium species. |
| MDA-2016-0021 |
27 October 2016 |
Total intravenous anaesthesia sets (TIVA) – risk of leakage during use - Manufactured by Global Components Medical Ltd |
| MDA-2016-0020 |
26 October 2016 |
Managing diabetes: patients should not change their insulin delivery device without checking with their healthcare specialist. |
| MDA-2016-0019 |
17 October 2016 |
Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) – Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy. |
| MDA-2016-0018 |
13 October 2016 |
Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS, manufactured by Physio-Control – risk of delay to defibrillation due to an intermittent component failure. Specific serial numbers are affected. |
| MDA-2016-0016 |
1 September 2016 |
Accu-Chek® Insight Insulin pump system: risk of over- or under-infusion of insulin, manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis. |
| MDA-2016-007 |
24 May 2016 |
Bipolar Quicksite And Quickflex Lead Model’s: 1056t, 1058t, 1156t and 1158t Manufactured By St Jude Medical. Risk Of Worsening Heart Failure Symptoms Due To Wear And/Or Abrasion Of Lead Insulation After Implantation. |
| MDA-2016-002 |
03 March 2016 |
Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME). |
