# FDA recall Z-2701-2017

> **Natus Medical Incorporated** · Class II · device recall initiated 2017-05-22.

## Product

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes.    Catalog Number/Description:    007168        PM3500 ASSY (15KW 208/120V)  007169        PM3000 ASSY (9KW 208/120V)  007169R     PM3 (9KW 208/120) REFURB  007170       PM3 ASSY (8.3KW 200V DELTA)  007171       PM3 ASSY (9KW 220V SING PH)  52640         PASTEURMATIC 3000 W/O BASKETS  52640R       PM 3000 w/o Baskets Refurb  52640-200  PM 3000 W/O BASKETS 200V  52640-220  PM 3000 W/O BASKETS 220V  52641          PASTEURMATIC 3000 W/BASKET S  52641R       PM 3000 w/ Baskets Refurb  52641-200  PM 3000 W BASKETS 200V  52641-220  PM 3000 W/ BASKETS 220V  52650          PASTEURMATIC 3500 W/O BASKET  52651          PASTEURMATIC 3500 W/BASKETS S

## 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.

## 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, WI, and WV and in the following countries: Canada, Colombia, Costa Rica, Ecuador, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Panama, Peru, Qatar, Saudi Arabia, Taiwan, Thailand, and Viet Nam.

## Key facts

- **Recall number:** Z-2701-2017
- **Recalling firm:** Natus Medical Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-07-19
- **Termination date:** 2019-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seattle, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2701-2017

## Citation

> AI Analytics. FDA recall Z-2701-2017. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-2701-2017. Source: US FDA. Licensed CC0.

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