FDA Medical Device Recalls (openFDA)
Philips Medical Systems: M3001A Philips Multi Measurement Server (MMS)
- Recall number
- Z-0183-2007
- Recalling firm
- Philips Medical Systems
- Product
- M3001A Philips Multi Measurement Server (MMS)
- Status
- Terminated
- Initiated
- 2006-09-21
- Posted
- 2006-11-16
- Terminated
- 2020-08-11
- Reason
- Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM
- Root cause
- Other
- Action
- Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.
- Quantity
- 69696 units
- Distribution
- Worldwide, including USA, Canada, Australia, China, Hong Kong, India, Indonesia, Japan, Phillipines, Singapore, Taiwan, Thailand, Vietnam, Argentina, Brazil, Chile, Colombia, El Salvador, Jamaica, Mexico, Nicaragua. Panama, Paraguay, Peru, Venezuela, Austria, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Mauritania, Mauritius, Netherlands, Norway, Oman, Slovenia, South Africa, Spain, Switzerland, Turkey, UAE, UK, Yemen, Zambia, Zimbabwe
- Lot, serial or model codes
- HW Revision B: M3001 A #AO1 with S/N DE512xxxx M3001A #A02 with S/N DE512xxxx HW Revision C M3001A #A01 and #A02 with S/N DE610xxxx With Sp)2 Firmware (Fw) Rev.: Sp02 DSP FW-Rev: A.01.41 or A.01.42
- 510(k) numbers
- K033715
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28