MEDICAL EQUIPMENT
Recalls and Risk Factors
This chart lists medical devices that have been recalled by
the FDA, resulting in tremendous expense and negative publicity. Several of
these recalls were due to battery holders or contact failure. The one thing
they have in common is that none of the affected companies’ products used MPD’s
battery holders and contacts. Many have turned to MPD-engineered solutions or
our line of off-the-shelf products to correct their defects and get back onto
the market.
|
Device Type |
FDA Category |
FDA Class |
No.Of FDA Recalls* |
Lawsuit Risk |
|
Accelerometers |
Not FDA Regulated |
Low |
||
|
864.5400 |
II |
10 |
Medium |
|
|
Automated External Defibrillators |
870.5310 |
III |
87 |
High |
|
Baby Breathing Monitors |
Not FDA Regulated |
Low |
||
|
Baby Monitors |
Not FDA Regulated |
Low |
||
|
Bathroom Scales |
Not FDA Regulated |
Low |
||
|
Blood Pressure Meters |
870.1130 |
II |
21 |
Low |
|
Body Fat Analyzers |
870.2770 |
II |
0 |
Low |
|
Cholesterol Meters |
862.1175 |
I |
0 |
Low |
|
Electrical Muscle Stimulators |
890.5850 |
II |
0 |
Low |
|
Fertility Monitors |
862.1155 |
II |
7 |
Low |
|
Glucose Meters |
862.1345 |
II |
52 |
High |
|
Impotence Pumps |
Not FDA Regulated |
Low |
||
|
Insulin Pumps |
880.5725 |
II |
9 |
High |
|
Iontophoresis Devices |
890.5525 |
II |
1 |
Low |
|
Massagers |
890.5660 |
I |
3 |
Low |
|
Nebulizers |
874.5220 |
I |
3 |
Low |
|
Oxygen Conservers |
868.5905 |
II |
1 |
Medium |
|
Pedometers |
Not FDA Regulated |
Low |
||
|
Pulse Oximeters |
870.2700 |
II |
8 |
Medium |
|
TENS Devices |
882.5890 |
II |
0 |
Low |
|
Thermometers |
Not FDA Regulated |
Low |
||
*As of Aug 15 2006
FDA
Device Class Summary:
Class I – Devices which have minimal potential for harm. Most of these devices are exempt from the majority of FDA regulations.
Class II – Devices which may cause harm to users, but for which there are special controls to ensure safety and effectiveness. The FDA must be notified before the device may be marketed, the device must be labeled correctly, and Good Manufacturing Practices must be followed. In addition to the above general controls, regulations specific to the device type must be followed.
Class III – Devices which sustain life or carry risk of injury. The FDA must approve the device before it may be marketed, in addition to following all Class II regulations.
We understand battery holders for medical electronics, does your vender ?
