The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of res
FDA device recall Z-2701-2017 · posted 2017-06-02 · Terminated
Recall details
- Recalling firm
- Natus Medical Incorporated
- Reason for recall
- Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
- Action taken
- Natus Medical sent an URGENT: RECALL NOTIFICATION MEDICAL DEVICE RECALL letter dated May 2017. Please refer to the accompanying Instructions to Disable the Pasteurmatic (DOC-022838), then complete and return the attached reply form. Should you require assistance in decommissioning your affected system please indicate option 2 on the reply form and you will be contacted to schedule an in- service. Natus may reimburse facilities for Olympic Pasteurmatic" 3000/3500 System purchases based on the age of the affected system as determined by the system serial number. There is no evidence to suggest there is a safety risk associated with the Olympic Pasteurmatic" 3000/3500 System device, nor have there been any safety incidences reported to Natus. Natus apologizes for any inconvenience. Please understand that this is part of our commitment to providing only the highest quality products and information to our customers. Please contact us at Natus_Quality_Programs@natus.com or (866) 940-7143 option #2 if you have any further questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MEC
- Quantity affected
- total 275 units (97 units in US and 178 units international)
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA
- Date initiated
- 2017-05-22
- Date posted
- 2017-06-02
- Date terminated
- 2019-07-03
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (K081094) | Olympic Medical Corp. | 2008-06-20 |